Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074132
Company: TEVA
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
03/27/1995 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/13/2015 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

04/13/2015 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

12/30/2010 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

10/19/2007 SUPPL-20 Labeling

Label is not available on this site.

07/02/2007 SUPPL-19 Labeling

Label is not available on this site.

04/11/2007 SUPPL-18 Labeling

Label is not available on this site.

07/20/2005 SUPPL-15 Labeling

Label is not available on this site.

02/20/2002 SUPPL-10 Labeling

Label is not available on this site.

08/30/2001 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

07/21/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/21/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/27/1997 SUPPL-5 Labeling

Label is not available on this site.

01/25/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/26/1995 SUPPL-1 Labeling

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 PHARM
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

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 PHARM
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 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 PHARM
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 PHARM
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

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