Application 215113

Type
ANDA
Sponsor
MSN

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
72205-088Doxepin HydrochlorideDoxepin HydrochlorideNovadoz Pharmaceuticals LLCANDACurrent
72205-089Doxepin HydrochlorideDoxepin HydrochlorideNovadoz Pharmaceuticals LLCANDACurrent
72205-090Doxepin HydrochlorideDoxepin HydrochlorideNovadoz Pharmaceuticals LLCANDACurrent
72205-091Doxepin HydrochlorideDoxepin HydrochlorideNovadoz Pharmaceuticals LLCANDACurrent
72205-092Doxepin HydrochlorideDoxepin HydrochlorideNovadoz Pharmaceuticals LLCANDACurrent