FDA.reportPublic FDA data

Application 202337

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDETABLET;ORALEQ 3MG BASENoNo
002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDETABLET;ORALEQ 6MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-5390Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-5390Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-5390Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-5391Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-5391Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-5391Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
72819-161DoxepinDoxepinArchis Pharma LLCANDACurrent
72819-162DoxepinDoxepinArchis Pharma LLCANDACurrent