Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088484
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE 10MG 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
07/26/1984 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
12/01/1998 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

09/11/1995 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

10/18/1995 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/28/1995 SUPPL-30 Labeling

Label is not available on this site.

09/10/1992 SUPPL-29 Labeling

Label is not available on this site.

06/19/1992 SUPPL-28 Labeling

Label is not available on this site.

03/15/1991 SUPPL-27 Labeling

Label is not available on this site.

08/04/1989 SUPPL-25 Labeling

Label is not available on this site.

06/27/1989 SUPPL-24 Labeling

Label is not available on this site.

03/15/1989 SUPPL-23 Labeling

Label is not available on this site.

06/16/1988 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/06/1988 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/06/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/06/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/09/1986 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/20/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/16/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/14/1985 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/14/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/14/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/27/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/14/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/14/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/27/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/27/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/27/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/14/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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