Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 005292
Company: SCHERING
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESTINYL | ETHINYL ESTRADIOL | 0.02MG | TABLET;ORAL | Discontinued | None | No | No |
| ESTINYL | ETHINYL ESTRADIOL | 0.05MG | TABLET;ORAL | Discontinued | None | No | No |
| ESTINYL | ETHINYL ESTRADIOL | 0.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/25/1943 | 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 |
|---|---|---|---|---|---|
| 05/31/2001 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/23/2001 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/09/2001 | SUPPL-22 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 12/04/2000 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/2000 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/18/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/23/1999 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/06/1998 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/17/1987 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/26/1986 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 03/27/1986 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/11/1980 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1980 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 01/31/1979 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/20/1978 | SUPPL-7 | Labeling |
Label is not available on this site. |