FDA.reportPublic FDA data

Application 214908

Type
ANDA
Sponsor
APPCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 10MG BASENoNo
002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 25MG BASENoNo
003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 50MG BASENoNo
004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 75MG BASENoNo
005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 100MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23155-794Doxepin HydrochlorideDoxepin HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-795Doxepin HydrochlorideDoxepin HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-796Doxepin HydrochlorideDoxepin HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-797Doxepin HydrochlorideDoxepin HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-798Doxepin HydrochlorideDoxepn HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
55801-527Doxepin HydrochlorideDoxepin HydrochlorideAppco Pharma LLCANDACurrent
55801-528Doxepin HydrochlorideDoxepin HydrochlorideAppco Pharma LLCANDACurrent
55801-529Doxepin HydrochlorideDoxepin HydrochlorideAppco Pharma LLCANDACurrent
55801-530Doxepin HydrochlorideDoxepin HydrochlorideAppco Pharma LLCANDACurrent
55801-531Doxepin HydrochlorideDoxepn HydrochlorideAppco Pharma LLCANDACurrent