Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083729
Company: TEVA

Products on ANDA 083729

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET;ORAL	Discontinued	None	No	No
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Discontinued	None	No	No
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083729

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/1974	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
07/07/2000	SUPPL-357	Manufacturing (CMC)-Facility		Label is not available on this site.
07/29/1997	SUPPL-356	Manufacturing (CMC)		Label is not available on this site.
06/18/1997	SUPPL-355	Manufacturing (CMC)		Label is not available on this site.
10/24/1996	SUPPL-354	Manufacturing (CMC)		Label is not available on this site.
10/10/1995	SUPPL-353	Labeling		Label is not available on this site.
02/08/1996	SUPPL-352	Manufacturing (CMC)		Label is not available on this site.
03/01/1995	SUPPL-350	Manufacturing (CMC)		Label is not available on this site.
09/19/1995	SUPPL-349	Manufacturing (CMC)		Label is not available on this site.
09/06/1994	SUPPL-348	Manufacturing (CMC)		Label is not available on this site.
06/17/1994	SUPPL-347	Manufacturing (CMC)		Label is not available on this site.
06/23/1993	SUPPL-346	Labeling		Label is not available on this site.
03/30/1992	SUPPL-345	Manufacturing (CMC)		Label is not available on this site.
04/12/1989	SUPPL-344	Manufacturing (CMC)		Label is not available on this site.
04/12/1989	SUPPL-343	Manufacturing (CMC)		Label is not available on this site.
04/12/1989	SUPPL-342	Manufacturing (CMC)		Label is not available on this site.
03/31/1988	SUPPL-340	Manufacturing (CMC)		Label is not available on this site.
11/04/1987	SUPPL-339	Manufacturing (CMC)		Label is not available on this site.
08/07/1987	SUPPL-338	Manufacturing (CMC)		Label is not available on this site.
09/10/1987	SUPPL-337	Manufacturing (CMC)		Label is not available on this site.
05/09/1986	SUPPL-336	Manufacturing (CMC)		Label is not available on this site.
03/12/1986	SUPPL-333	Manufacturing (CMC)		Label is not available on this site.
03/04/1986	SUPPL-331	Manufacturing (CMC)		Label is not available on this site.
02/05/1986	SUPPL-330	Manufacturing (CMC)		Label is not available on this site.
12/21/1984	SUPPL-328	Manufacturing (CMC)		Label is not available on this site.
02/05/1986	SUPPL-327	Manufacturing (CMC)		Label is not available on this site.
07/09/1984	SUPPL-326	Manufacturing (CMC)		Label is not available on this site.
02/03/1984	SUPPL-324	Manufacturing (CMC)		Label is not available on this site.
09/19/1983	SUPPL-323	Manufacturing (CMC)		Label is not available on this site.
03/17/1983	SUPPL-321	Manufacturing (CMC)		Label is not available on this site.
03/17/1983	SUPPL-320	Manufacturing (CMC)		Label is not available on this site.
12/16/1982	SUPPL-319	Manufacturing (CMC)		Label is not available on this site.
12/16/1982	SUPPL-317	Manufacturing (CMC)		Label is not available on this site.
06/25/1982	SUPPL-314	Manufacturing (CMC)		Label is not available on this site.
02/03/1984	SUPPL-313	Manufacturing (CMC)		Label is not available on this site.
02/03/1984	SUPPL-312	Manufacturing (CMC)		Label is not available on this site.
02/03/1984	SUPPL-311	Manufacturing (CMC)		Label is not available on this site.
06/25/1982	SUPPL-306	Manufacturing (CMC)		Label is not available on this site.
04/13/1982	SUPPL-303	Manufacturing (CMC)		Label is not available on this site.