Drugs@FDA: FDA-Approved Drugs
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| MEGACE | MEGESTROL ACETATE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| MEGACE | MEGESTROL ACETATE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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. |