Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213441
Company: ZYDUS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription AB No No
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription AB No No
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription AB No No
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/24/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

NORTRIPTYLINE HYDROCHLORIDE

CAPSULE;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 073556 MAYNE PHARMA
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 075520 TARO
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 074132 TEVA
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 213441 ZYDUS
PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription Yes AB 018013 SPECGX LLC

CAPSULE;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 213441 ZYDUS

CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 073556 MAYNE PHARMA
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 075520 TARO
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 074132 TEVA
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 213441 ZYDUS
PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription Yes AB 018013 SPECGX LLC

CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 073556 MAYNE PHARMA
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 075520 TARO
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 074132 TEVA
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 213441 ZYDUS
PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription Yes AB 018013 SPECGX LLC

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