Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084937
Company: SANDOZ

Products on ANDA 084937

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084937

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/20/1976	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
05/24/2023	SUPPL-129	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/02/2016	SUPPL-128	Labeling-Package Insert		Label is not available on this site.
07/17/2014	SUPPL-127	Labeling-Package Insert		Label is not available on this site.
03/10/2008	SUPPL-120	Labeling		Label is not available on this site.
06/25/2007	SUPPL-119	Labeling		Label is not available on this site.
06/15/2005	SUPPL-118	Labeling		Label is not available on this site.
04/19/2002	SUPPL-115	Manufacturing (CMC)-Control		Label is not available on this site.
05/09/2001	SUPPL-114	Manufacturing (CMC)-Control		Label is not available on this site.
10/16/2001	SUPPL-113	Manufacturing (CMC)-Control		Label is not available on this site.
10/31/2000	SUPPL-112	Manufacturing (CMC)-Control		Label is not available on this site.
05/11/1999	SUPPL-111	Labeling		Label is not available on this site.
05/05/1999	SUPPL-110	Manufacturing (CMC)		Label is not available on this site.
06/01/1999	SUPPL-108	Labeling		Label is not available on this site.
05/01/1999	SUPPL-107	Manufacturing (CMC)		Label is not available on this site.
02/09/2007	SUPPL-106	Labeling		Label is not available on this site.
03/21/1995	SUPPL-102	Labeling		Label is not available on this site.
04/06/1995	SUPPL-101	Manufacturing (CMC)		Label is not available on this site.
03/11/1994	SUPPL-100	Labeling		Label is not available on this site.
04/15/1991	SUPPL-99	Labeling		Label is not available on this site.
11/07/1989	SUPPL-98	Labeling		Label is not available on this site.
09/15/1989	SUPPL-97	Labeling		Label is not available on this site.
10/02/1990	SUPPL-96	Manufacturing (CMC)		Label is not available on this site.
02/22/1988	SUPPL-94	Manufacturing (CMC)		Label is not available on this site.
02/22/1988	SUPPL-93	Labeling		Label is not available on this site.
02/22/1988	SUPPL-92	Manufacturing (CMC)		Label is not available on this site.
02/22/1988	SUPPL-91	Manufacturing (CMC)		Label is not available on this site.
02/22/1988	SUPPL-90	Manufacturing (CMC)		Label is not available on this site.
02/22/1988	SUPPL-89	Manufacturing (CMC)		Label is not available on this site.
04/09/1987	SUPPL-87	Manufacturing (CMC)		Label is not available on this site.
07/30/1986	SUPPL-85	Manufacturing (CMC)		Label is not available on this site.
07/30/1986	SUPPL-82	Manufacturing (CMC)		Label is not available on this site.
07/30/1986	SUPPL-81	Manufacturing (CMC)		Label is not available on this site.
07/30/1986	SUPPL-80	Manufacturing (CMC)		Label is not available on this site.
01/16/1986	SUPPL-79	Manufacturing (CMC)		Label is not available on this site.
12/27/1985	SUPPL-78	Manufacturing (CMC)		Label is not available on this site.
10/21/1983	SUPPL-73	Manufacturing (CMC)		Label is not available on this site.
07/21/1983	SUPPL-71	Manufacturing (CMC)		Label is not available on this site.
12/10/1982	SUPPL-69	Manufacturing (CMC)		Label is not available on this site.
12/10/1982	SUPPL-68	Manufacturing (CMC)		Label is not available on this site.
06/09/1982	SUPPL-65	Manufacturing (CMC)		Label is not available on this site.
06/09/1982	SUPPL-64	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 084937

IMIPRAMINE HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	040903	LEADING
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	040751	OXFORD PHARMS
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	084937	SANDOZ
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	088276	STRIDES PHARMA
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	081050	SUN PHARM INDUSTRIES