Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010611
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOTESTIN FLUOXYMESTERONE 2MG TABLET;ORAL Discontinued None No No
HALOTESTIN FLUOXYMESTERONE 5MG TABLET;ORAL Discontinued None No No
HALOTESTIN FLUOXYMESTERONE 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
10/15/1956 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/20/1991 SUPPL-38 Labeling

Label is not available on this site.

05/20/1991 SUPPL-37 Labeling

Label is not available on this site.

11/02/1990 SUPPL-36 Labeling

Label is not available on this site.

05/05/1989 SUPPL-35 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/05/1989 SUPPL-34 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/05/1987 SUPPL-33 Labeling

Label is not available on this site.

06/18/1984 SUPPL-32 Labeling

Label is not available on this site.

06/14/1978 SUPPL-21 Labeling

Label is not available on this site.

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