FDA.reportPublic FDA data

Application 073556

Type
ANDA
Sponsor
MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALEQ 75MG BASENoNo
002NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASENoNo
003NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALEQ 25MG BASENoNo
004NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALEQ 50MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-600Nortriptyline HydrochlorideNortriptyline HydrochlorideRebel Distributors CorpANDACurrent
43063-722Nortriptyline HydrochlorideNortriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-722Nortriptyline HydrochlorideNortriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-722Nortriptyline HydrochlorideNortriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-722Nortriptyline HydrochlorideNortriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-722Nortriptyline HydrochlorideNortriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
51862-015Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-015Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-015Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-015Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-016Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-016Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-016Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-016Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-017Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-017Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-017Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-017Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-018Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-018Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-945Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-945Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-946Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-946Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-947Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-947Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-948Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
51862-948Nortriptyline HydrochlorideNortriptyline HydrochlorideMayne Pharma Inc.ANDACurrent
61919-510NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-510NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-742Nortriptyline HCLNortriptyline HCLDirect_RxANDACurrent
68071-2327Nortriptyline HydrochlorideNortriptyline HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8158Nortriptyline HydrochlorideNortriptyline HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-8202Nortriptyline HydrochlorideNortriptyline HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-3485Nortriptyline HydrochlorideNortriptyline HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3485Nortriptyline HydrochlorideNortriptyline HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3543Nortriptyline HydrochlorideNortriptyline HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-578Nortriptyline HydrochlorideNortriptyline HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-1726Nortriptyline HydrochlorideNortriptyline HydrochlorideBryant Ranch PrepackANDACurrent
71335-1743Nortriptyline HydrochlorideNortriptyline HydrochlorideBryant Ranch PrepackANDACurrent
71335-1773Nortriptyline HydrochlorideNortriptyline HydrochlorideBryant Ranch PrepackANDACurrent
71335-2199Nortriptyline HydrochlorideNortriptyline HydrochlorideBryant Ranch PrepackANDACurrent
72189-177NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEDIRECT RXANDACurrent