FDA.reportPublic FDA data

Application 071437

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 25MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog.

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
2019-07-19 19:46 UTC2019-07A071437-001DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1987-11-09ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07A071437-001AB1ea99ee380514…

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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6971Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
49884-218Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent