Application 210675

Type
ANDA
Sponsor
EPIC PHARMA LLC

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 100MG BASENoNo
004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 50MG BASENoNo
005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 75MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42806-529Doxepin HydrochlorideDoxepin HydrochlorideEpic Pharma, LLCANDACurrent
42806-529Doxepin HydrochlorideDoxepin HydrochlorideEpic Pharma, LLCANDACurrent
42806-530Doxepin HydrochlorideDoxepin HydrochlorideEpic Pharma, LLCANDACurrent
42806-530Doxepin HydrochlorideDoxepin HydrochlorideEpic Pharma, LLCANDACurrent
42806-531Doxepin HydrochlorideDoxepin HydrochlorideEpic Pharma, LLCANDACurrent
42806-532Doxepin HydrochlorideDoxepin HydrochlorideEpic Pharma, LLCANDACurrent
42806-533Doxepin HydrochlorideDoxepin HydrochlorideEpic Pharma, LLCANDACurrent
42806-533Doxepin HydrochlorideDoxepin HydrochlorideEpic Pharma, LLCANDACurrent