Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074430
Company: ACTAVIS TOTOWA

Products on ANDA 074430

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074430

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
09/06/2024	SUPPL-22	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
01/21/2020	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 074430

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	209785	ALEMBIC
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	208105	AMNEAL PHARMS CO
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	072103	CHARTWELL RX
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	204963	INGENUS PHARMS LLC
NORPRAMIN	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	Yes	AB	014399	VALIDUS PHARMS

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	209785	ALEMBIC
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET;ORAL	Prescription	No	AB	208105	AMNEAL PHARMS CO
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET;ORAL	Prescription	No	AB	072103	CHARTWELL RX
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET;ORAL	Prescription	No	AB	204963	INGENUS PHARMS LLC
NORPRAMIN	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET;ORAL	Prescription	Yes	AB	014399	VALIDUS PHARMS