Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072102
Company: SANDOZ

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 75MG TABLET;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
06/20/1988 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
09/27/2019 SUPPL-31 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
03/30/2015 SUPPL-28 Labeling-Package Insert

Label is not available on this site.
03/30/2015 SUPPL-27 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
03/17/2010 SUPPL-25 Labeling-Package Insert

Label is not available on this site.
10/19/2007 SUPPL-20 Labeling

Label is not available on this site.
10/19/2007 SUPPL-17 Labeling

Label is not available on this site.
07/08/2005 SUPPL-16 Labeling

Label is not available on this site.
03/19/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
02/07/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
05/05/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
04/05/1995 SUPPL-9 Labeling

Label is not available on this site.
07/25/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
03/17/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
08/17/1993 SUPPL-6 Labeling

Label is not available on this site.
07/28/1992 SUPPL-5 Labeling

Label is not available on this site.
04/02/1992 SUPPL-4 Labeling

Label is not available on this site.
07/31/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
06/21/1989 SUPPL-2 Labeling

Label is not available on this site.

DESIPRAMINE HYDROCHLORIDE

TABLET;ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 071602 ACTAVIS TOTOWA
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 208105 AMNEAL PHARMS CO
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 205153 ANI PHARMS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 207433 HERITAGE PHARMS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 204963 NOVAST LABS
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 072102 SANDOZ
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription Yes AB 014399 US PHARM HOLDINGS

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