Drugs@FDA: FDA Approved Drug Products

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

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