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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075520
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription AB No No
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 10MG 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
05/08/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75520ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/16/2020 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/13/2015 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/13/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

02/19/2009 SUPPL-3 Labeling

Label is not available on this site.

08/03/2007 SUPPL-2 Labeling

Label is not available on this site.

07/20/2005 SUPPL-1 Labeling

Label is not available on this site.

NORTRIPTYLINE HYDROCHLORIDE

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
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
PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 75MG 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 073556 MAYNE PHARMA
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 075520 TARO
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 074132 TEVA
PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription Yes AB 018013 SPECGX LLC

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
PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription Yes AB 018013 SPECGX LLC
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