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 1.

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
2026-07-26 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
2026-07-26 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 4 of 5 · 89 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEA-S Medication Solutions55a20aa1-fc9e-487d-9f8d-c4abf77ae2d22024-07-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEAdvanced Rx of Tennessee, LLC1cec730e-3218-ddf6-e063-6294a90a916e2024-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEEpic Pharma, LLC5f0f6fee-2497-4915-b58b-bf369efcfd792024-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEA-S Medication Solutions890248d7-73b1-4ed3-b252-85775defdf342024-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.9ee26b24-7121-3107-e053-2995a90ac61c2024-06-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackec948b3d-4853-41bb-9f01-faf28fe369e52024-05-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack6e22050f-95ee-410a-b770-0c32fb8b321b2024-01-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepacka4c804e3-4706-48d8-b928-b22c2dcaeed82024-01-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack2cacce3a-4986-44a8-b4aa-6edb076d87bf2023-11-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack0cbf87df-c447-4225-81f5-92c4bc3ef81d2023-10-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LP7cfbb3d0-f19f-4977-ad0f-77676a8c6f832023-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAmneal Pharmaceuticals NY LLCdd8d5edd-7b08-4061-86e6-c4179da89c0d2023-08-17Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack41046d94-1443-4bbd-96d0-8463604ae4592023-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS14002bad-2577-436d-91ca-ec1b80ab0c972023-03-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEAlembic Pharmaceuticals Limited842b595b-dc54-4898-a178-1d2241cc065f2023-01-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LPacb696a8-a74c-4c5d-9ce3-88f67558c2f22022-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LP6ce7fde2-2d47-4238-9beb-555d352f46572022-05-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
doxepin hydrochlorideDOXEPIN HYDROCHLORIDECurrax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven5b4dba99-6b66-4091-94f1-bf5f021c688a2022-01-20Warnings, Adverse reactionsName fallback
brand name: doxepin hydrochloride
generic name: DOXEPIN HYDROCHLORIDE