FDA.report

Application 075520

Type
ANDA
Sponsor
TARO

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALEQ 50MG BASENoNo
002NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALEQ 75MG BASENoNo
003NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALEQ 25MG BASENoNo
004NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-897Nortriptyline HydrochlorideNortriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-897Nortriptyline HydrochlorideNortriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-897Nortriptyline HydrochlorideNortriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-897Nortriptyline HydrochlorideNortriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-897Nortriptyline HydrochlorideNortriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-897Nortriptyline HydrochlorideNortriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-897Nortriptyline HydrochlorideNortriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-371Nortriptyline HydrochlorideNortriptyline HydrochlorideMedsource PharmaceuticalsANDACurrent
50090-0507Nortriptyline HydrochlorideNortriptyline HydrochlorideA-S Medication SolutionsANDACurrent
50090-0507Nortriptyline HydrochlorideNortriptyline HydrochlorideA-S Medication SolutionsANDACurrent
50090-0537Nortriptyline HydrochlorideNortriptyline HydrochlorideA-S Medication SolutionsANDACurrent
50090-0537Nortriptyline HydrochlorideNortriptyline HydrochlorideA-S Medication SolutionsANDACurrent
50090-0537Nortriptyline HydrochlorideNortriptyline HydrochlorideA-S Medication SolutionsANDACurrent
50090-1323Nortriptyline HydrochlorideNortriptyline HydrochlorideA-S Medication SolutionsANDACurrent
50090-1323Nortriptyline HydrochlorideNortriptyline HydrochlorideA-S Medication SolutionsANDACurrent
50268-603Nortriptyline HydrochlorideNortriptyline HydrochlorideAvPAKANDACurrent
50268-603Nortriptyline HydrochlorideNortriptyline HydrochlorideAvPAKANDACurrent
50268-604Nortriptyline HydrochlorideNortriptyline HydrochlorideAvPAKANDACurrent
50268-604Nortriptyline HydrochlorideNortriptyline HydrochlorideAvPAKANDACurrent
50268-605Nortriptyline HydrochlorideNortriptyline HydrochlorideAvPAKANDACurrent
50268-605Nortriptyline HydrochlorideNortriptyline HydrochlorideAvPAKANDACurrent
50436-4022Nortriptyline HydrochlorideNortriptyline HydrochlorideUnit Dose ServicesANDACurrent
51672-4001Nortriptyline HydrochlorideNortriptyline HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4001Nortriptyline HydrochlorideNortriptyline HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4001Nortriptyline HydrochlorideNortriptyline HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4002Nortriptyline HydrochlorideNortriptyline HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4002Nortriptyline HydrochlorideNortriptyline HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4002Nortriptyline HydrochlorideNortriptyline HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4003Nortriptyline HydrochlorideNortriptyline HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4003Nortriptyline HydrochlorideNortriptyline HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4003Nortriptyline HydrochlorideNortriptyline HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4004Nortriptyline HydrochlorideNortriptyline HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4004Nortriptyline HydrochlorideNortriptyline HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4004Nortriptyline HydrochlorideNortriptyline HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
53217-254Nortriptyline HydrochlorideNortriptyline HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
55700-501Nortriptyline HydrochlorideNortriptyline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-501Nortriptyline HydrochlorideNortriptyline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-501Nortriptyline HydrochlorideNortriptyline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-501Nortriptyline HydrochlorideNortriptyline HydrochlorideQuality Care Products LLCANDACurrent
55700-501Nortriptyline HydrochlorideNortriptyline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-501Nortriptyline HydrochlorideNortriptyline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-501Nortriptyline HydrochlorideNortriptyline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-668Nortriptyline HydrochlorideNortriptyline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-668Nortriptyline HydrochlorideNortriptyline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-668Nortriptyline HydrochlorideNortriptyline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-668Nortriptyline HydrochlorideNortriptyline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-668Nortriptyline HydrochlorideNortriptyline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
58118-4002Nortriptyline HydrochlorideNortriptyline HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
58118-4002Nortriptyline HydrochlorideNortriptyline HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
58118-4002Nortriptyline HydrochlorideNortriptyline HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
60687-265Nortriptyline HydrochlorideNortriptyline HydrochlorideAmerican Health PackagingANDACurrent
60687-265Nortriptyline HydrochlorideNortriptyline HydrochlorideAmerican Health PackagingANDACurrent
60687-265Nortriptyline HydrochlorideNortriptyline HydrochlorideAmerican Health PackagingANDACurrent
60687-265Nortriptyline HydrochlorideNortriptyline HydrochlorideAmerican Health PackagingANDACurrent
60687-281Nortriptyline HydrochlorideNortriptyline HydrochlorideAmerican Health PackagingANDACurrent
60687-281Nortriptyline HydrochlorideNortriptyline HydrochlorideAmerican Health PackagingANDACurrent
60687-281Nortriptyline HydrochlorideNortriptyline HydrochlorideAmerican Health PackagingANDACurrent
60687-281Nortriptyline HydrochlorideNortriptyline HydrochlorideAmerican Health PackagingANDACurrent
60687-293Nortriptyline HydrochlorideNortriptyline HydrochlorideAmerican Health PackagingANDACurrent
60687-293Nortriptyline HydrochlorideNortriptyline HydrochlorideAmerican Health PackagingANDACurrent
60687-293Nortriptyline HydrochlorideNortriptyline HydrochlorideAmerican Health PackagingANDACurrent
60687-293Nortriptyline HydrochlorideNortriptyline HydrochlorideAmerican Health PackagingANDACurrent
60760-401Nortriptyline HydrochlorideNortriptyline HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-508Nortriptyline HydrochlorideNortriptyline HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-811Nortriptyline HydrochlorideNortriptyline HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
61919-285NORTRIPTYLINE HCINORTRIPTYLINE HCIDirect_RxANDACurrent
61919-285NORTRIPTYLINE HCINORTRIPTYLINE HCIDirect_RxANDACurrent
61919-285NORTRIPTYLINE HCINORTRIPTYLINE HCIDirect_RxANDACurrent
61919-285NORTRIPTYLINE HCINORTRIPTYLINE HCIDirect_RxANDACurrent
61919-285NORTRIPTYLINE HCINORTRIPTYLINE HCIDirect_RxANDACurrent
61919-353NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-853Nortriptyline HCLNortriptyline HCLDirect_RxANDACurrent
61919-853Nortriptyline HCLNortriptyline HCLDirect_RxANDACurrent
63187-396Nortriptyline HydrochlorideNortriptyline HydrochlorideProficient Rx LPANDACurrent
63187-396Nortriptyline HydrochlorideNortriptyline HydrochlorideProficient Rx LPANDACurrent
63187-396Nortriptyline HydrochlorideNortriptyline HydrochlorideProficient Rx LPANDACurrent
63187-396Nortriptyline HydrochlorideNortriptyline HydrochlorideProficient Rx LPANDACurrent
63187-715Nortriptyline HydrochlorideNortriptyline HydrochlorideProficient Rx LPANDACurrent
63187-715Nortriptyline HydrochlorideNortriptyline HydrochlorideProficient Rx LPANDACurrent
63187-798Nortriptyline HydrochlorideNortriptyline HydrochlorideProficient Rx LPANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.Date
309210ORIG12000-05-08