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 3 of 5 · 87 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
doxepin hydrochlorideDOXEPIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.554ab06f-6420-42b3-89d1-d97554c237d82025-08-06Warnings, Adverse reactionsName fallback
brand name: doxepin hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDELifestar Pharma LLCfdaf3bd7-c456-40bd-8bc3-2b67eb1846c82025-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEMylan Institutional Inc.137a953b-3c48-405f-86a6-ff778cb7f5f22025-07-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEAlembic Pharmaceuticals Inc.4920401a-cde5-404b-82aa-c3c0e89110652025-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
DoxepinDOXEPIN HYDROCHLORIDEBryant Ranch Prepack207bb11e-6029-4506-92d2-2d8a776b94082025-05-02Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
DoxepinDOXEPIN HYDROCHLORIDEBryant Ranch Prepackbc3b0401-df4a-46a2-a29b-3d70e72aa88b2025-05-01Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDERising Pharma Holdings, Inc.66c6af99-9909-4b18-a43b-898a1c4a34d72025-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
DoxepinDOXEPIN HYDROCHLORIDEStrides Pharma Science Limited399866d5-3fa6-46d0-9c62-492d5997bc4f2025-03-21Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack3bc72772-22ae-4f29-97ff-4a552b4df6d02025-01-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBryant Ranch Prepack06e027bb-516d-4a1d-b5a0-a66c051eb3672025-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEdirect rxb56cdaee-6187-c763-e053-2995a90acc3f2025-01-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2bf7d838-6274-4d8a-91cb-b27e1e81d2732025-01-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf900bac4-02f2-6bf3-e053-6394a90a21612024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEGolden State Medical Supply, Inc.00ef7d0b-4bb9-cd5b-e063-6294a90abc352024-12-24Warnings, Adverse reactionsName fallback
brand name: Doxepin hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBryant Ranch Prepack19c8ad61-4e4f-4c59-b196-34a4e470459f2024-11-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack13da67ec-370c-4647-8440-80fd55f1398e2024-11-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackeb6954cf-e96b-4e54-961d-6b094384bac92024-09-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBoswell Pharmacy Services LLC d/b/a BPS Wholesale214b6c28-7418-5ebd-e063-6394a90ae8332024-09-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBoswell Pharmacy Services LLC d/b/a BPS Wholesale214bae5d-36e2-47ae-e063-6294a90a7ddd2024-09-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackefcae0f7-3491-470f-beea-1aff221782432024-08-20Boxed 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.