Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073556
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription AB No No
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/30/1992 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
07/15/2015 SUPPL-52 Labeling-Package Insert

Label is not available on this site.

07/15/2015 SUPPL-50 Labeling-Package Insert

Label is not available on this site.

02/20/2008 SUPPL-34 Labeling

Label is not available on this site.

07/03/2007 SUPPL-32 Labeling

Label is not available on this site.

04/12/2007 SUPPL-29 Labeling

Label is not available on this site.

11/01/2006 SUPPL-24 Labeling

Label is not available on this site.

07/26/2005 SUPPL-22 Labeling

Label is not available on this site.

01/04/2002 SUPPL-16 Labeling

Label is not available on this site.

04/25/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/26/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/07/1997 SUPPL-11 Labeling

Label is not available on this site.

12/05/1995 SUPPL-10 Labeling

Label is not available on this site.

05/25/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/11/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/25/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-4 Labeling

Label is not available on this site.

NORTRIPTYLINE HYDROCHLORIDE

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

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

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