Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072101
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 50MG 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
05/24/1988 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-36 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/30/2015 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

03/30/2015 SUPPL-31 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/17/2010 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

10/19/2007 SUPPL-24 Labeling

Label is not available on this site.

10/19/2007 SUPPL-21 Labeling

Label is not available on this site.

07/08/2005 SUPPL-20 Labeling

Label is not available on this site.

08/13/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/22/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/22/1999 SUPPL-11 Labeling

Label is not available on this site.

03/22/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/27/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/27/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/05/1995 SUPPL-7 Labeling

Label is not available on this site.

03/01/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/17/1993 SUPPL-5 Labeling

Label is not available on this site.

07/28/1992 SUPPL-4 Labeling

Label is not available on this site.

04/02/1992 SUPPL-3 Labeling

Label is not available on this site.

06/21/1989 SUPPL-2 Labeling

Label is not available on this site.

DESIPRAMINE HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 071588 ACTAVIS TOTOWA
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 208105 AMNEAL PHARMS CO
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 205153 ANI PHARMS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 207433 HERITAGE PHARMS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 204963 NOVAST LABS
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 072101 SANDOZ
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription Yes AB 014399 US PHARM HOLDINGS

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