Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089386
Company: ESI
Company: ESI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCRIN | 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 |
|---|---|---|---|---|---|---|---|
| 09/09/1987 | 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 |
|---|---|---|---|---|---|
| 11/28/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/04/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/21/1989 | SUPPL-8 | Bioequivalence |
Label is not available on this site. |
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| 12/13/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 12/06/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 02/21/1990 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/21/1990 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/21/1990 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/30/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |