Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088342
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOXYMESTERONE FLUOXYMESTERONE 10MG TABLET;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/21/1983 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
04/06/1992 SUPPL-25 Labeling

Label is not available on this site.

12/11/1991 SUPPL-24 Labeling

Label is not available on this site.

07/02/1991 SUPPL-22 Labeling

Label is not available on this site.

03/08/1990 SUPPL-21 Labeling

Label is not available on this site.

11/07/1989 SUPPL-20 Labeling

Label is not available on this site.

01/12/1989 SUPPL-19 Labeling

Label is not available on this site.

12/26/1987 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/26/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/17/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/17/1986 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/17/1986 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/20/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/27/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/17/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/17/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/17/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/17/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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