@cliwant/mcp-sam-gov 1.3.0 → 1.5.0

package/dist/openfda-device.d.ts.map

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package/dist/openfda-device.js

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+/**
+ * openfda-device.ts — openFDA 510(k) DEVICE CLEARANCES (api.fda.gov) — the
+ * MEDICAL-DEVICE REGULATORY lane (ADR-0056). The FDA's premarket-notification
+ * (510(k)) clearances: the applicant, the device, the clearance number (K-number),
+ * the decision (date + description), the clearance type, the product code, the
+ * advisory committee, and geography.
+ *
+ * ★ THIS IS THE SAME SOURCE + ENVELOPE + CRUX as openfda.ts (ADR-0054). Same host
+ *   (api.fda.gov), same response envelope `{ meta:{ results:{ skip, limit, total }},
+ *   results:[…] }`, same ★no-match→HTTP-404-NOT_FOUND-as-honest-empty crux, same
+ *   optional query-key K-test, same fixed-host SSRF idiom, same structured-only
+ *   (no raw Lucene passthrough) search assembly. It REUSES openfda.ts's `fetchOpenfda`
+ *   (the SSRF-guarded classified fetch) and `readOpenfdaError` (the error-body reader)
+ *   verbatim — the 404-reclassification logic is NOT reinvented — plus `luceneQuote`
+ *   (the phrase-escape), `openfdaApiKey` (the optional-key env seam), and `OPENFDA_HOST`.
+ *
+ *   GET https://api.fda.gov/device/510k.json
+ *       ?search=<lucene>&limit=<1..100>&skip=<offset>[&api_key=<KEY>]
+ *   → { meta:{ disclaimer, results:{ skip, limit, total }}, results:[ {…} ] }
+ *     (live total ~175507).
+ *
+ * ★ HONESTY (mirrors openfda.ts exactly):
+ *   [P1]  totalAvailable = `meta.results.total` EXACT (e.g. 175507), NEVER
+ *         results.length. skip/limit offset pagination:
+ *         hasMore = skip + returned < total; nextOffset = hasMore ? skip+returned : null.
+ *   [★P2] a 404 whose body is `{error:{code:"NOT_FOUND"}}` (a no-match query OR an
+ *         unknown field) ⇒ HONEST EMPTY (returned:0, totalAvailable:0) — NOT thrown,
+ *         NOT not_found. Any OTHER 4xx (e.g. a 400 syntax error) ⇒ invalid_input
+ *         surfacing openFDA's message. 5xx/timeout ⇒ upstream_unavailable THROW. A
+ *         200 non-JSON body ⇒ schema_drift. (Reuses openfda.ts's exact fetch path.)
+ *   [P3]  dates (`decision_date`, YYYY-MM-DD) and every scalar surfaced as a STRING
+ *         via `str` (null-never-empty-string) — no numeric coercion; never fabricated.
+ *   [P4]  `meta.results` or `results` absent / non-array ⇒ driftError (never a
+ *         fabricated empty).
+ *   [K-test] OPTIONAL OPENFDA_API_KEY: when set it rides `&api_key=` ONLY (openFDA has
+ *         no header option — the query-key is inherent). Mitigation: the `label` is
+ *         host+path ONLY (`openfda:/device/510k`, NO query), so no token reaches
+ *         ToolError.upstreamEndpoint; `_meta.source` names the MODE only; the key is
+ *         ABSENT from the serialized {data,_meta}, notes, and any log. Unset ⇒ keyless.
+ *   [SSRF] fixed host `api.fda.gov` (fetchOpenfda asserts hostname/protocol +
+ *         redirect:"error"); all filter VALUES are Lucene-escaped + phrase-quoted and
+ *         ride URLSearchParams `search=`; limit/skip are integers; state is charclass
+ *         `^[A-Za-z]{2}$`. No raw Lucene passthrough — structured only, injection-safe.
+ */
+import { ToolErrorCarrier, errorFromResponse } from "./errors.js";
+import { driftError } from "./datasource.js";
+import { str } from "./coerce.js";
+import { withMeta } from "./meta.js";
+import { OPENFDA_HOST, fetchOpenfda, readOpenfdaError, luceneQuote, openfdaApiKey, } from "./openfda.js";
+// state filter charclass (a 2-letter US state/territory postal code).
+const STATE_RE = /^[A-Za-z]{2}$/;
+const DEFAULT_LIMIT = 25;
+const MAX_LIMIT = 100;
+/** host+path-only label (→ ToolError.upstreamEndpoint); NEVER carries the key. */
+const DEVICE_LABEL = "openfda:/device/510k";
+// ─── Honesty notes (ADR-0056 required set) ────────────────────────
+const NOT_DETERMINATION_NOTE = "openFDA 510(k) device clearances are FDA-published premarket-notification records; treat the decision/date/clearance-type as of the source's last publication. This is reference data, not a live regulatory determination.";
+const KEYLESS_NOTE = "Keyless: no OPENFDA_API_KEY is set. openFDA allows ~1000 requests/day without a key; a free key raises the rate limit (get one at https://open.fda.gov/apis/authentication/).";
+const KEYED_NOTE = "OPENFDA_API_KEY is set — it rides ONLY the &api_key= query parameter to api.fda.gov (openFDA has no header option), raising the rate limit. Its value is NEVER logged, echoed, or placed in this response.";
+const NO_FILTER_NOTE = "No structured filters were applied — this is an unscoped scan of the WHOLE 510(k) device-clearance collection. Add applicant / deviceName / productCode / clearanceType / kNumber / state to scope the result set.";
+/** Map ONE openFDA 510(k) result row → the curated shape. Every scalar via `str`. */
+function mapClearance(row) {
+    const r = (row ?? {});
+    return {
+        applicant: str(r.applicant),
+        deviceName: str(r.device_name),
+        kNumber: str(r.k_number),
+        decisionDate: str(r.decision_date),
+        decisionDescription: str(r.decision_description),
+        clearanceType: str(r.clearance_type),
+        productCode: str(r.product_code),
+        advisoryCommittee: str(r.advisory_committee),
+        state: str(r.state),
+    };
+}
+/**
+ * Assemble the openFDA `search=` Lucene string from structured 510(k) filters — each
+ * value Lucene-escaped + phrase-quoted (reusing openfda.ts's `luceneQuote`), joined by
+ * ` AND `. Returns "" when no filter is present (openFDA then returns the whole
+ * collection). The clause → field mapping is FIXED here; a caller can never inject a
+ * raw field:value (no raw Lucene passthrough).
+ */
+export function buildDeviceSearch(f) {
+    const clauses = [];
+    if (f.applicant !== undefined)
+        clauses.push(`applicant:${luceneQuote(f.applicant)}`);
+    if (f.deviceName !== undefined)
+        clauses.push(`device_name:${luceneQuote(f.deviceName)}`);
+    if (f.productCode !== undefined)
+        clauses.push(`product_code:${luceneQuote(f.productCode)}`);
+    if (f.clearanceType !== undefined)
+        clauses.push(`clearance_type:${luceneQuote(f.clearanceType)}`);
+    if (f.kNumber !== undefined)
+        clauses.push(`k_number:${luceneQuote(f.kNumber)}`);
+    if (f.state !== undefined)
+        clauses.push(`state:${luceneQuote(f.state.toUpperCase())}`);
+    return clauses.join(" AND ");
+}
+/**
+ * Search openFDA 510(k) DEVICE CLEARANCES with structured filters → curated clearance
+ * rows + honest `_meta`. KEYLESS (an OPTIONAL OPENFDA_API_KEY only raises the rate
+ * limit). totalAvailable = meta.results.total (EXACT); skip/limit offset pagination.
+ * ★A no-match query (openFDA HTTP 404 NOT_FOUND) ⇒ an honest empty, never a throw.
+ */
+export async function deviceClearances(args) {
+    // ── Validate + default the inputs (belt-and-suspenders behind the server Zod; a
+    //    DIRECT handler call bypasses Zod). ──
+    if (args.state !== undefined && !STATE_RE.test(args.state)) {
+        throw new ToolErrorCarrier({
+            kind: "invalid_input",
+            retryable: false,
+            message: `Invalid state ${JSON.stringify(args.state)} — expected a 2-letter US state/territory postal code (^[A-Za-z]{2}$), e.g. "CA".`,
+            upstreamEndpoint: DEVICE_LABEL,
+        });
+    }
+    const limit = clampLimit(args.limit);
+    const skip = clampSkip(args.skip);
+    // ── Assemble the query (structured-only; all VALUES via URLSearchParams — no
+    //    host/path steer). The OPTIONAL key rides ONLY here in &api_key=. ──
+    const filters = {
+        applicant: args.applicant,
+        deviceName: args.deviceName,
+        productCode: args.productCode,
+        clearanceType: args.clearanceType,
+        kNumber: args.kNumber,
+        state: args.state,
+    };
+    const search = buildDeviceSearch(filters);
+    const filtersApplied = [];
+    if (args.applicant !== undefined)
+        filtersApplied.push("applicant");
+    if (args.deviceName !== undefined)
+        filtersApplied.push("deviceName");
+    if (args.productCode !== undefined)
+        filtersApplied.push("productCode");
+    if (args.clearanceType !== undefined)
+        filtersApplied.push("clearanceType");
+    if (args.kNumber !== undefined)
+        filtersApplied.push("kNumber");
+    if (args.state !== undefined)
+        filtersApplied.push("state");
+    const params = new URLSearchParams();
+    if (search !== "")
+        params.set("search", search);
+    params.set("limit", String(limit));
+    params.set("skip", String(skip));
+    const key = openfdaApiKey();
+    if (key !== undefined)
+        params.set("api_key", key); // OPTIONAL — &api_key= ONLY
+    const url = `https://${OPENFDA_HOST}/device/510k.json?${params.toString()}`;
+    // ── Fetch + classify. ★P2 CRUX: a 404 whose body is {error:{code:"NOT_FOUND"}} is
+    //    a genuine no-match (or an unknown field) ⇒ an HONEST EMPTY, never a thrown
+    //    not_found. Any OTHER 4xx (e.g. 400 syntax) ⇒ invalid_input surfacing openFDA's
+    //    message; a 5xx/429 ⇒ the shared taxonomy THROWS. (fetchOpenfda/readOpenfdaError
+    //    are the SAME helpers as openfda.ts — the 404-reclassify logic is not reinvented.) ──
+    const res = await fetchOpenfda(url, DEVICE_LABEL);
+    if (res.status === 404) {
+        const { code, message } = await readOpenfdaError(res);
+        if (code === "NOT_FOUND") {
+            // Honest empty — NOT thrown, NOT not_found (the openFDA no-match idiom).
+            return emptyResult(limit, skip, filtersApplied, key !== undefined);
+        }
+        // A non-NOT_FOUND 404 ⇒ the shared not_found taxonomy (never a fake-empty).
+        throw new ToolErrorCarrier({
+            ...errorFromResponse(res, DEVICE_LABEL),
+            message: message
+                ? `openFDA returned HTTP 404 at ${DEVICE_LABEL}: ${message}`
+                : `Resource not found at ${DEVICE_LABEL} (HTTP 404).`,
+        });
+    }
+    if (res.status >= 400 && res.status < 500 && res.status !== 429) {
+        // A 4xx OTHER than 404/429 (e.g. 400 syntax) ⇒ invalid_input surfacing the
+        // openFDA error message (a caller-fixable request, never a fake-empty).
+        const { message } = await readOpenfdaError(res);
+        throw new ToolErrorCarrier({
+            kind: "invalid_input",
+            retryable: false,
+            message: message
+                ? `openFDA rejected the request (HTTP ${res.status}) at ${DEVICE_LABEL}: ${message}`
+                : `Bad request (HTTP ${res.status}) at ${DEVICE_LABEL}.`,
+            upstreamStatus: res.status,
+            upstreamEndpoint: DEVICE_LABEL,
+        });
+    }
+    if (!res.ok) {
+        // 429 → rate_limited; 5xx → upstream_unavailable (a DOWN service is NEVER an empty
+        // result). Delegated to the shared errors.ts taxonomy.
+        throw new ToolErrorCarrier(errorFromResponse(res, DEVICE_LABEL));
+    }
+    // ── 200 ⇒ parse JSON; a non-JSON body ⇒ r.json() SyntaxError ⇒ schema_drift (never
+    //    read as an empty result). ──
+    let body;
+    try {
+        body = await res.json();
+    }
+    catch (e) {
+        if (e instanceof SyntaxError) {
+            throw driftError(DEVICE_LABEL, `openFDA ${DEVICE_LABEL} returned a non-JSON body at HTTP 200 — schema drift (never read as an empty result).`);
+        }
+        throw e;
+    }
+    // ── [P4] meta.results (the total carrier) and results (the rows) MUST be present +
+    //    well-shaped; anything else is drift, never a fabricated empty. ──
+    const b = (body ?? {});
+    const meta = (b.meta ?? {});
+    const metaResults = meta.results;
+    if (metaResults === undefined ||
+        metaResults === null ||
+        typeof metaResults !== "object") {
+        throw driftError(DEVICE_LABEL, `openFDA ${DEVICE_LABEL} shape drift — meta.results (the skip/limit/total carrier) is missing.`);
+    }
+    if (!Array.isArray(b.results)) {
+        throw driftError(DEVICE_LABEL, `openFDA ${DEVICE_LABEL} shape drift — results must be an array.`);
+    }
+    const clearances = b.results.map(mapClearance);
+    const returned = clearances.length;
+    // ── [P1] totalAvailable = meta.results.total EXACT (the REAL total), NEVER
+    //    results.length. skip/limit offset pagination. ──
+    const rawTotal = metaResults.total;
+    const totalAvailable = typeof rawTotal === "number" && Number.isFinite(rawTotal) ? rawTotal : null;
+    const hasMore = totalAvailable !== null && skip + returned < totalAvailable;
+    const nextOffset = hasMore ? skip + returned : null;
+    const notes = [NOT_DETERMINATION_NOTE, keyNote(key !== undefined)];
+    if (filtersApplied.length === 0)
+        notes.push(NO_FILTER_NOTE);
+    return withMeta({ clearances }, {
+        // MODE only — never the key value (K-test).
+        source: `${OPENFDA_HOST} /device/510k (openFDA 510(k) device clearances; ${key !== undefined ? "OPENFDA_API_KEY rate-limit key applied" : "keyless"})`,
+        keylessMode: true, // a keyless tool; the optional key only raises the rate limit
+        returned,
+        totalAvailable,
+        filtersApplied,
+        filtersDropped: [],
+        fieldsUnavailable: [],
+        pagination: { offset: skip, limit, hasMore, nextOffset },
+        notes,
+    });
+}
+// ─── Small helpers ────────────────────────────────────────────────
+function keyNote(hasKey) {
+    return hasKey ? KEYED_NOTE : KEYLESS_NOTE;
+}
+/** An honest empty result (★P2: a 404 NOT_FOUND no-match) — returned:0, total:0. */
+function emptyResult(limit, skip, filtersApplied, hasKey) {
+    return withMeta({ clearances: [] }, {
+        source: `${OPENFDA_HOST} /device/510k (openFDA 510(k) device clearances; ${hasKey ? "OPENFDA_API_KEY rate-limit key applied" : "keyless"})`,
+        keylessMode: true,
+        returned: 0,
+        totalAvailable: 0,
+        filtersApplied,
+        filtersDropped: [],
+        fieldsUnavailable: [],
+        pagination: { offset: skip, limit, hasMore: false, nextOffset: null },
+        notes: [
+            "No 510(k) device clearances matched this query (openFDA returned HTTP 404 NOT_FOUND — the source's honest no-match). This is an exact empty, not an error.",
+            NOT_DETERMINATION_NOTE,
+            keyNote(hasKey),
+        ],
+    });
+}
+function clampLimit(v) {
+    if (typeof v !== "number" || !Number.isFinite(v))
+        return DEFAULT_LIMIT;
+    const n = Math.floor(v);
+    if (n < 1)
+        return 1;
+    if (n > MAX_LIMIT)
+        return MAX_LIMIT;
+    return n;
+}
+function clampSkip(v) {
+    if (typeof v !== "number" || !Number.isFinite(v))
+        return 0;
+    const n = Math.floor(v);
+    return n < 0 ? 0 : n;
+}
+//# sourceMappingURL=openfda-device.js.map

package/dist/openfda-device.js.map

@@ -0,0 +1 @@
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package/dist/openfda-drugsfda.d.ts

@@ -0,0 +1,72 @@
+/**
+ * openfda-drugsfda.ts — openFDA DRUG APPROVALS (Drugs@FDA, api.fda.gov) — the
+ * PHARMA REGULATORY-APPROVAL lane. FDA-approved drug applications (NDA/ANDA/BLA):
+ * the sponsor, the application number, each approved product (brand/generic name,
+ * dosage form, route, marketing status), and the submission/approval history.
+ * Answers "what drugs did sponsor X get approved, and which are still marketed" —
+ * pharma vendor product/approval intelligence.
+ *
+ * ★ SAME SOURCE + ENVELOPE + CRUX as openfda.ts / openfda-device.ts (ADR-0054/0056).
+ *   Same host (api.fda.gov), same envelope `{ meta:{ results:{ skip,limit,total }},
+ *   results:[…] }`, same ★no-match→HTTP-404-NOT_FOUND-as-honest-empty crux, same
+ *   optional query-key K-test, same fixed-host SSRF idiom, same structured-only (no
+ *   raw Lucene passthrough) search. REUSES openfda.ts's `fetchOpenfda`,
+ *   `readOpenfdaError`, `luceneQuote`, `openfdaApiKey`, `OPENFDA_HOST` verbatim.
+ *
+ *   GET https://api.fda.gov/drug/drugsfda.json?search=<lucene>&limit=&skip=[&api_key=]
+ *   → { meta:{ results:{ skip,limit,total }}, results:[ { application_number,
+ *       sponsor_name, products:[…], submissions:[…] } ] }.
+ *
+ * ★ HONESTY (mirrors the siblings exactly): [P1] totalAvailable = meta.results.total
+ *   EXACT (never results.length); skip/limit offset pagination. [★P2] 404 NOT_FOUND
+ *   ⇒ honest empty (never thrown); other 4xx ⇒ invalid_input surfacing openFDA's
+ *   message; 5xx/429 ⇒ THROW. [P3] every scalar via `str` (null-never-""); nested
+ *   products/submissions arrays default to [] and each field is str (never fabricated).
+ *   [P4] meta.results / results absent-or-mis-shaped ⇒ driftError. [K-test] the
+ *   OPTIONAL OPENFDA_API_KEY rides ONLY &api_key=; label/source name mode only.
+ *   [SSRF] fixed host; all VALUES Lucene-escaped + phrase-quoted via URLSearchParams.
+ */
+import { type MetaBundle } from "./meta.js";
+export type DrugsfdaProduct = {
+    brandName: string | null;
+    genericIngredients: {
+        name: string | null;
+        strength: string | null;
+    }[];
+    dosageForm: string | null;
+    route: string | null;
+    marketingStatus: string | null;
+};
+export type DrugsfdaSubmission = {
+    submissionType: string | null;
+    submissionNumber: string | null;
+    submissionStatus: string | null;
+    submissionStatusDate: string | null;
+    submissionClass: string | null;
+};
+export type DrugsfdaApplication = {
+    applicationNumber: string | null;
+    sponsorName: string | null;
+    products: DrugsfdaProduct[];
+    submissions: DrugsfdaSubmission[];
+};
+export type DrugsfdaFilters = {
+    sponsorName?: string;
+    brandName?: string;
+    activeIngredient?: string;
+    applicationNumber?: string;
+};
+export declare function buildDrugsfdaSearch(f: DrugsfdaFilters): string;
+export type DrugApprovalsArgs = DrugsfdaFilters & {
+    limit?: number;
+    skip?: number;
+};
+/**
+ * Search openFDA Drugs@FDA drug-approval applications with structured filters →
+ * curated application rows (sponsor, application number, approved products, submission
+ * history) + honest `_meta`. KEYLESS (OPTIONAL OPENFDA_API_KEY only raises the rate
+ * limit). totalAvailable = meta.results.total (EXACT); skip/limit pagination. A
+ * no-match query (openFDA HTTP 404 NOT_FOUND) ⇒ an honest empty, never a throw.
+ */
+export declare function drugApprovals(args: DrugApprovalsArgs): Promise<MetaBundle>;
+//# sourceMappingURL=openfda-drugsfda.d.ts.map

package/dist/openfda-drugsfda.d.ts.map

@@ -0,0 +1 @@
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package/dist/openfda-drugsfda.js

@@ -0,0 +1,230 @@
+/**
+ * openfda-drugsfda.ts — openFDA DRUG APPROVALS (Drugs@FDA, api.fda.gov) — the
+ * PHARMA REGULATORY-APPROVAL lane. FDA-approved drug applications (NDA/ANDA/BLA):
+ * the sponsor, the application number, each approved product (brand/generic name,
+ * dosage form, route, marketing status), and the submission/approval history.
+ * Answers "what drugs did sponsor X get approved, and which are still marketed" —
+ * pharma vendor product/approval intelligence.
+ *
+ * ★ SAME SOURCE + ENVELOPE + CRUX as openfda.ts / openfda-device.ts (ADR-0054/0056).
+ *   Same host (api.fda.gov), same envelope `{ meta:{ results:{ skip,limit,total }},
+ *   results:[…] }`, same ★no-match→HTTP-404-NOT_FOUND-as-honest-empty crux, same
+ *   optional query-key K-test, same fixed-host SSRF idiom, same structured-only (no
+ *   raw Lucene passthrough) search. REUSES openfda.ts's `fetchOpenfda`,
+ *   `readOpenfdaError`, `luceneQuote`, `openfdaApiKey`, `OPENFDA_HOST` verbatim.
+ *
+ *   GET https://api.fda.gov/drug/drugsfda.json?search=<lucene>&limit=&skip=[&api_key=]
+ *   → { meta:{ results:{ skip,limit,total }}, results:[ { application_number,
+ *       sponsor_name, products:[…], submissions:[…] } ] }.
+ *
+ * ★ HONESTY (mirrors the siblings exactly): [P1] totalAvailable = meta.results.total
+ *   EXACT (never results.length); skip/limit offset pagination. [★P2] 404 NOT_FOUND
+ *   ⇒ honest empty (never thrown); other 4xx ⇒ invalid_input surfacing openFDA's
+ *   message; 5xx/429 ⇒ THROW. [P3] every scalar via `str` (null-never-""); nested
+ *   products/submissions arrays default to [] and each field is str (never fabricated).
+ *   [P4] meta.results / results absent-or-mis-shaped ⇒ driftError. [K-test] the
+ *   OPTIONAL OPENFDA_API_KEY rides ONLY &api_key=; label/source name mode only.
+ *   [SSRF] fixed host; all VALUES Lucene-escaped + phrase-quoted via URLSearchParams.
+ */
+import { ToolErrorCarrier, errorFromResponse } from "./errors.js";
+import { driftError } from "./datasource.js";
+import { str } from "./coerce.js";
+import { withMeta } from "./meta.js";
+import { OPENFDA_HOST, fetchOpenfda, readOpenfdaError, luceneQuote, openfdaApiKey, } from "./openfda.js";
+const DEFAULT_LIMIT = 25;
+const MAX_LIMIT = 100;
+/** host+path-only label (→ ToolError.upstreamEndpoint); NEVER carries the key. */
+const DRUGSFDA_LABEL = "openfda:/drug/drugsfda";
+// ─── Honesty notes ────────────────────────────────────────────────
+const NOT_DETERMINATION_NOTE = "openFDA Drugs@FDA records are FDA-published drug-application data; treat approval/marketing status as of the source's last publication. This is reference data, not a live regulatory determination.";
+const KEYLESS_NOTE = "Keyless: no OPENFDA_API_KEY is set. openFDA allows ~1000 requests/day without a key; a free key raises the rate limit (get one at https://open.fda.gov/apis/authentication/).";
+const KEYED_NOTE = "OPENFDA_API_KEY is set — it rides ONLY the &api_key= query parameter to api.fda.gov (openFDA has no header option), raising the rate limit. Its value is NEVER logged, echoed, or placed in this response.";
+const NO_FILTER_NOTE = "No structured filters were applied — this is an unscoped scan of the WHOLE Drugs@FDA collection. Add sponsorName / brandName / activeIngredient / applicationNumber to scope the result set.";
+const MARKETING_NOTE = "products[].marketingStatus is the FDA marketing category (e.g. 'Prescription', 'Over-the-counter', 'Discontinued', 'None (Tentative Approval)') — a 'Discontinued' product is NOT an approval revocation. submissions[] is the application's action history (ORIG approval + subsequent supplements).";
+/** Map ONE Drugs@FDA result row → the curated shape. Every scalar via `str`. */
+function mapApplication(row) {
+    const r = (row ?? {});
+    const products = Array.isArray(r.products) ? r.products : [];
+    const submissions = Array.isArray(r.submissions) ? r.submissions : [];
+    return {
+        applicationNumber: str(r.application_number),
+        sponsorName: str(r.sponsor_name),
+        products: products.map((p) => {
+            const pr = (p ?? {});
+            const ings = Array.isArray(pr.active_ingredients) ? pr.active_ingredients : [];
+            return {
+                brandName: str(pr.brand_name),
+                genericIngredients: ings.map((a) => {
+                    const ai = (a ?? {});
+                    return { name: str(ai.name), strength: str(ai.strength) };
+                }),
+                dosageForm: str(pr.dosage_form),
+                route: str(pr.route),
+                marketingStatus: str(pr.marketing_status),
+            };
+        }),
+        submissions: submissions.map((s) => {
+            const su = (s ?? {});
+            return {
+                submissionType: str(su.submission_type),
+                submissionNumber: str(su.submission_number),
+                submissionStatus: str(su.submission_status),
+                submissionStatusDate: str(su.submission_status_date),
+                submissionClass: str(su.submission_class_code_description),
+            };
+        }),
+    };
+}
+export function buildDrugsfdaSearch(f) {
+    const clauses = [];
+    if (f.sponsorName !== undefined)
+        clauses.push(`sponsor_name:${luceneQuote(f.sponsorName)}`);
+    if (f.brandName !== undefined)
+        clauses.push(`products.brand_name:${luceneQuote(f.brandName)}`);
+    if (f.activeIngredient !== undefined)
+        clauses.push(`products.active_ingredients.name:${luceneQuote(f.activeIngredient)}`);
+    if (f.applicationNumber !== undefined)
+        clauses.push(`application_number:${luceneQuote(f.applicationNumber)}`);
+    return clauses.join(" AND ");
+}
+/**
+ * Search openFDA Drugs@FDA drug-approval applications with structured filters →
+ * curated application rows (sponsor, application number, approved products, submission
+ * history) + honest `_meta`. KEYLESS (OPTIONAL OPENFDA_API_KEY only raises the rate
+ * limit). totalAvailable = meta.results.total (EXACT); skip/limit pagination. A
+ * no-match query (openFDA HTTP 404 NOT_FOUND) ⇒ an honest empty, never a throw.
+ */
+export async function drugApprovals(args) {
+    const limit = clampLimit(args.limit);
+    const skip = clampSkip(args.skip);
+    const filters = {
+        sponsorName: args.sponsorName,
+        brandName: args.brandName,
+        activeIngredient: args.activeIngredient,
+        applicationNumber: args.applicationNumber,
+    };
+    const search = buildDrugsfdaSearch(filters);
+    const filtersApplied = [];
+    if (args.sponsorName !== undefined)
+        filtersApplied.push("sponsorName");
+    if (args.brandName !== undefined)
+        filtersApplied.push("brandName");
+    if (args.activeIngredient !== undefined)
+        filtersApplied.push("activeIngredient");
+    if (args.applicationNumber !== undefined)
+        filtersApplied.push("applicationNumber");
+    const params = new URLSearchParams();
+    if (search !== "")
+        params.set("search", search);
+    params.set("limit", String(limit));
+    params.set("skip", String(skip));
+    const key = openfdaApiKey();
+    if (key !== undefined)
+        params.set("api_key", key); // OPTIONAL — &api_key= ONLY
+    const url = `https://${OPENFDA_HOST}/drug/drugsfda.json?${params.toString()}`;
+    const res = await fetchOpenfda(url, DRUGSFDA_LABEL);
+    if (res.status === 404) {
+        const { code, message } = await readOpenfdaError(res);
+        if (code === "NOT_FOUND") {
+            return emptyResult(limit, skip, filtersApplied, key !== undefined);
+        }
+        throw new ToolErrorCarrier({
+            ...errorFromResponse(res, DRUGSFDA_LABEL),
+            message: message
+                ? `openFDA returned HTTP 404 at ${DRUGSFDA_LABEL}: ${message}`
+                : `Resource not found at ${DRUGSFDA_LABEL} (HTTP 404).`,
+        });
+    }
+    if (res.status >= 400 && res.status < 500 && res.status !== 429) {
+        const { message } = await readOpenfdaError(res);
+        throw new ToolErrorCarrier({
+            kind: "invalid_input",
+            retryable: false,
+            message: message
+                ? `openFDA rejected the request (HTTP ${res.status}) at ${DRUGSFDA_LABEL}: ${message}`
+                : `Bad request (HTTP ${res.status}) at ${DRUGSFDA_LABEL}.`,
+            upstreamStatus: res.status,
+            upstreamEndpoint: DRUGSFDA_LABEL,
+        });
+    }
+    if (!res.ok) {
+        throw new ToolErrorCarrier(errorFromResponse(res, DRUGSFDA_LABEL));
+    }
+    let body;
+    try {
+        body = await res.json();
+    }
+    catch (e) {
+        if (e instanceof SyntaxError) {
+            throw driftError(DRUGSFDA_LABEL, `openFDA ${DRUGSFDA_LABEL} returned a non-JSON body at HTTP 200 — schema drift (never read as an empty result).`);
+        }
+        throw e;
+    }
+    const b = (body ?? {});
+    const meta = (b.meta ?? {});
+    const metaResults = meta.results;
+    if (metaResults === undefined || metaResults === null || typeof metaResults !== "object") {
+        throw driftError(DRUGSFDA_LABEL, `openFDA ${DRUGSFDA_LABEL} shape drift — meta.results (the skip/limit/total carrier) is missing.`);
+    }
+    if (!Array.isArray(b.results)) {
+        throw driftError(DRUGSFDA_LABEL, `openFDA ${DRUGSFDA_LABEL} shape drift — results must be an array.`);
+    }
+    const applications = b.results.map(mapApplication);
+    const returned = applications.length;
+    const rawTotal = metaResults.total;
+    const totalAvailable = typeof rawTotal === "number" && Number.isFinite(rawTotal) ? rawTotal : null;
+    const hasMore = totalAvailable !== null && skip + returned < totalAvailable;
+    const nextOffset = hasMore ? skip + returned : null;
+    const notes = [NOT_DETERMINATION_NOTE, MARKETING_NOTE, keyNote(key !== undefined)];
+    if (filtersApplied.length === 0)
+        notes.push(NO_FILTER_NOTE);
+    return withMeta({ applications }, {
+        source: `${OPENFDA_HOST} /drug/drugsfda (openFDA Drugs@FDA approvals; ${key !== undefined ? "OPENFDA_API_KEY rate-limit key applied" : "keyless"})`,
+        keylessMode: true,
+        returned,
+        totalAvailable,
+        filtersApplied,
+        filtersDropped: [],
+        fieldsUnavailable: [],
+        pagination: { offset: skip, limit, hasMore, nextOffset },
+        notes,
+    });
+}
+// ─── Small helpers ────────────────────────────────────────────────
+function keyNote(hasKey) {
+    return hasKey ? KEYED_NOTE : KEYLESS_NOTE;
+}
+function emptyResult(limit, skip, filtersApplied, hasKey) {
+    return withMeta({ applications: [] }, {
+        source: `${OPENFDA_HOST} /drug/drugsfda (openFDA Drugs@FDA approvals; ${hasKey ? "OPENFDA_API_KEY rate-limit key applied" : "keyless"})`,
+        keylessMode: true,
+        returned: 0,
+        totalAvailable: 0,
+        filtersApplied,
+        filtersDropped: [],
+        fieldsUnavailable: [],
+        pagination: { offset: skip, limit, hasMore: false, nextOffset: null },
+        notes: [
+            "No Drugs@FDA applications matched this query (openFDA returned HTTP 404 NOT_FOUND — the source's honest no-match). This is an exact empty, not an error.",
+            NOT_DETERMINATION_NOTE,
+            keyNote(hasKey),
+        ],
+    });
+}
+function clampLimit(v) {
+    if (typeof v !== "number" || !Number.isFinite(v))
+        return DEFAULT_LIMIT;
+    const n = Math.floor(v);
+    if (n < 1)
+        return 1;
+    if (n > MAX_LIMIT)
+        return MAX_LIMIT;
+    return n;
+}
+function clampSkip(v) {
+    if (typeof v !== "number" || !Number.isFinite(v))
+        return 0;
+    const n = Math.floor(v);
+    return n < 0 ? 0 : n;
+}
+//# sourceMappingURL=openfda-drugsfda.js.map

package/dist/openfda-drugsfda.js.map

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