FDA.reportPublic FDA data

Application 213919

Type
ANDA
Sponsor
SUN PHARMA CANADA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECREAM;TOPICAL5%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213919-001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDE5%CREAM / TOPICALAB2026-04-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A213919-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213919-001DOXEPIN HYDROCHLORIDE5%CREAM / TOPICALAB2026-04-2884e616aacf4f…
2026-08-18 06:07:402026-07A213919-001DOXEPIN HYDROCHLORIDE5%CREAM / TOPICALAB2026-04-28caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213919-001DOXEPIN HYDROCHLORIDE5%CREAM / TOPICALAB2026-04-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A213919-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A213919-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213919-001AB1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 5 · 87 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDESafecor Health, LLCa2297f75-c498-419b-aa29-057271313a7f2026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1ede17e6-19e9-455c-ad16-8029a590735c2026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.d2a91b99-513d-4894-ad6d-02d2028a22902026-01-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDELeading Pharma, LLCe6a4cb10-1928-4abe-8797-404c9ddc37dd2025-12-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDELeading Pharma, LLCd5df4beb-8048-4b83-aa59-19876437001d2025-12-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1496dfc1-de50-471c-be87-1f1e2b70ab5a2025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEA-S Medication Solutionse0460c02-3dae-4b19-845c-2ffcfb587f6d2025-12-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDERedpharm Drug37451a61-ccb1-57b3-e063-6294a90a25922025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEChartwell RX, LLC33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32025-12-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEAjanta Pharma USA Inc.1513c98c-e7ef-4009-b932-6757048bb86a2025-11-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.8f7e9677-cc84-414b-8eb8-33993d285bb32025-11-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBryant Ranch Prepack09a70f17-f934-4b4b-9277-6351d906ab472025-10-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack55f7d7b5-b747-49ac-9bf0-1510987b02912025-10-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEMylan Pharmaceuticals Inc.1533343b-f1ed-4c3a-bb36-23a748452b052025-10-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack94ee3c14-0ccc-4329-b012-63679a699a672025-10-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEFirst Nation Group, LLC3d4f84a4-07a1-4d0e-85f5-dcd43b236a422025-09-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDENorthStar RxLLC03cef3a6-a63d-4082-a491-451b24227d9d2025-09-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEMajor Pharmaceuticalsdf3b6be0-6a64-4174-b351-dab2061f290e2025-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.89ed6385-cf6a-458e-81ea-c7f3fead41c52025-09-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAurobindo Pharma Limitedf3c242dd-426e-4c69-8f21-2645361d5f272025-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.