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Drugs@FDA: FDA-Approved Drugs

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

Products on ANDA 072102

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072102

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.

Therapeutic Equivalents for ANDA 072102

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	209785	ALEMBIC PHARMS
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	208105	AMNEAL PHARMS CO
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	207433	HERITAGE PHARMS
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	VALIDUS PHARMS

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