FDA.reportPublic FDA data

Application 213441

Type
ANDA
Sponsor
ZYDUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASENoNo
0020NORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALNoNo
003NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALEQ 50MG BASENoNo
004NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALEQ 75MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70710-1153Nortriptyline HydrochlorideNortriptyline HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1154Nortriptyline HydrochlorideNortriptyline HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1155Nortriptyline HydrochlorideNortriptyline HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1156Nortriptyline HydrochlorideNortriptyline HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1612Nortriptyline HydrochlorideNortriptyline HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1613Nortriptyline HydrochlorideNortriptyline HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1614Nortriptyline HydrochlorideNortriptyline HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1615Nortriptyline HydrochlorideNortriptyline HydrochlorideCadila Healthcare LimitedANDACurrent