Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071766
Company: ACTAVIS TOTOWA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 100MG 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
10/05/1987 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
01/05/2015 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

03/25/2010 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

11/28/2007 SUPPL-22 Labeling

Label is not available on this site.

11/28/2007 SUPPL-21 Labeling

Label is not available on this site.

05/19/2006 SUPPL-20 Labeling

Label is not available on this site.

08/04/2005 SUPPL-19 Labeling

Label is not available on this site.

02/02/2000 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

12/27/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/27/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/05/1995 SUPPL-13 Labeling

Label is not available on this site.

05/30/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/30/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/18/1993 SUPPL-8 Labeling

Label is not available on this site.

07/09/1992 SUPPL-7 Labeling

Label is not available on this site.

06/24/1992 SUPPL-6 Labeling

Label is not available on this site.

02/12/1992 SUPPL-5 Labeling

Label is not available on this site.

03/29/1990 SUPPL-4 Bioequivalence

Label is not available on this site.

03/31/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DESIPRAMINE HYDROCHLORIDE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 071766 ACTAVIS TOTOWA
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 208105 AMNEAL PHARMS CO
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 205153 ANI PHARMS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 207433 HERITAGE PHARMS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 204963 NOVAST LABS
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 072103 SANDOZ
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription Yes AB 014399 US PHARM HOLDINGS

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