Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074430
Company: ACTAVIS TOTOWA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB No No
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 150MG 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
02/09/1996 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-17 Labeling-Package Insert

Label is not available on this site.

03/25/2010 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

11/28/2007 SUPPL-11 Labeling

Label is not available on this site.

11/28/2007 SUPPL-10 Labeling

Label is not available on this site.

05/19/2006 SUPPL-9 Labeling

Label is not available on this site.

08/04/2005 SUPPL-8 Labeling

Label is not available on this site.

02/02/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

12/09/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/07/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DESIPRAMINE HYDROCHLORIDE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 074430 ACTAVIS TOTOWA
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 208105 AMNEAL PHARMS CO
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 205153 ANI PHARMS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 207433 HERITAGE PHARMS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 204963 NOVAST LABS
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 072099 SANDOZ
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AB 014399 US PHARM HOLDINGS

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 074430 ACTAVIS TOTOWA
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 208105 AMNEAL PHARMS CO
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 205153 ANI PHARMS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 207433 HERITAGE PHARMS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 204963 NOVAST LABS
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 072104 SANDOZ
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription Yes AB 014399 US PHARM HOLDINGS

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