Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017247
Company: HEXIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SANOREX MAZINDOL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
SANOREX MAZINDOL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
06/14/1973 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/17/2001 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

02/27/1996 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

10/17/1995 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1994 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/1995 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1992 SUPPL-36 Labeling

Label is not available on this site.

08/02/1991 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1994 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/1990 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1989 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

11/18/1986 SUPPL-29 Labeling

Label is not available on this site.

06/25/1981 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

01/21/1981 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/06/1982 SUPPL-25 Labeling

Label is not available on this site.

01/16/1979 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

03/23/1979 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/19/1979 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1977 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/20/1976 SUPPL-19 Labeling

Label is not available on this site.

05/10/1976 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/31/1976 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/06/1975 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/1974 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/1974 SUPPL-11 Labeling

Label is not available on this site.

11/15/1974 SUPPL-10 Labeling

Label is not available on this site.

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