Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016979
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEGACE MEGESTROL ACETATE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MEGACE MEGESTROL ACETATE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
08/18/1971 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
01/06/2003 SUPPL-52 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16979slr052ltr.pdf
08/27/2002 SUPPL-51 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16979slr051ltr.pdf
06/15/2001 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

01/31/2001 SUPPL-49 Labeling

Label is not available on this site.

11/15/1999 SUPPL-48 Labeling

Label is not available on this site.

09/04/1997 SUPPL-47 Labeling

Label is not available on this site.

06/27/1994 SUPPL-46 Labeling

Label is not available on this site.

08/11/1993 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

03/14/1991 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

03/04/1991 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/1989 SUPPL-41 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/08/1989 SUPPL-40 Labeling

Label is not available on this site.

01/26/1989 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/12/1988 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

03/07/1988 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1988 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

11/25/1985 SUPPL-33 Labeling

Label is not available on this site.

11/13/1987 SUPPL-31 Labeling

Label is not available on this site.

09/06/1990 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/23/1985 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1984 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/1984 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1990 SUPPL-25 Labeling

Label is not available on this site.

11/19/1982 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/24/1984 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/1984 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/1982 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1983 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/11/1981 SUPPL-18 Labeling

Label is not available on this site.

03/29/1979 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1980 SUPPL-16 Labeling

Label is not available on this site.

06/20/1979 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/15/1977 SUPPL-14 Labeling

Label is not available on this site.

11/23/1976 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/23/1976 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/1976 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1976 SUPPL-10 Labeling

Label is not available on this site.

07/07/1976 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1975 SUPPL-8 Unspecified

Label is not available on this site.

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