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 5 of 5 · 87 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAppco Pharma LLCabf4c515-8888-4733-80a0-fd4e1cdb84a22021-04-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LPe98f371e-f7fe-4c8f-9491-6eb4c53d43ad2021-02-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEContract Pharmacal Corp.abbf7078-a012-4e1a-e053-2995a90a792d2020-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC10d9eba6-30d1-448a-8d92-a1a02df033032017-09-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
PRUDOXINDOXEPIN HYDROCHLORIDEMylan Pharmaceuticals Inc.ca53346b-8ab3-4722-98f6-cf272706d3fa2017-06-29Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
ZonalonDOXEPIN HYDROCHLORIDEMylan Pharmaceuticals Inc.5f302247-525e-4acc-852b-00eb1d79af4b2017-06-14Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEMylan Pharmaceuticals Inc.b4771ea7-c19b-4182-bb23-c1473ab583fa2017-05-24Warnings, 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.