Drugs@FDA: FDA-Approved Drugs
Company: AMARIN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMEN | 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 |
|---|---|---|---|---|---|---|---|
| 05/15/1974 | 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 |
|---|---|---|---|---|---|
| 07/08/1997 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1997 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/29/1994 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/28/1994 | SUPPL-38 | Labeling |
Label is not available on this site. |
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| 02/03/1994 | SUPPL-37 | Labeling |
Label is not available on this site. |
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| 01/29/1993 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/25/1991 | SUPPL-35 | Labeling |
Label is not available on this site. |
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| 03/28/1991 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/27/1992 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/1990 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 02/10/1989 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/10/1989 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/23/1987 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1986 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1986 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/08/1986 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/16/1985 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/16/1985 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/16/1985 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/22/1984 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/22/1984 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |