Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010976
Company: GD SEARLE LLC
Company: GD SEARLE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ENOVID | MESTRANOL; NORETHYNODREL | 0.075MG;5MG | TABLET;ORAL-20 | Discontinued | None | No | No |
| ENOVID | MESTRANOL; NORETHYNODREL | 0.15MG;9.85MG | TABLET;ORAL | Discontinued | None | No | No |
| ENOVID | MESTRANOL; NORETHYNODREL | 0.075MG;5MG | TABLET;ORAL | Discontinued | None | No | No |
| ENOVID-E | MESTRANOL; NORETHYNODREL | 0.1MG;2.5MG | TABLET;ORAL-20 | Discontinued | None | No | No |
| ENOVID-E 21 | MESTRANOL; NORETHYNODREL | 0.1MG;2.5MG | TABLET;ORAL-21 | 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 |
|---|---|---|---|---|---|---|---|
| 03/09/1961 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 10/23/1986 | SUPPL-73 | Labeling |
Label is not available on this site. |
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| 06/10/1986 | SUPPL-72 | Labeling |
Label is not available on this site. |
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| 03/13/1986 | SUPPL-71 | Labeling |
Label is not available on this site. |
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| 06/05/1985 | SUPPL-70 | Labeling |
Label is not available on this site. |
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| 04/05/1985 | SUPPL-69 | Labeling |
Label is not available on this site. |
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| 09/18/1984 | SUPPL-68 | Labeling |
Label is not available on this site. |
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| 03/06/1984 | SUPPL-66 | Labeling |
Label is not available on this site. |
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| 06/03/1983 | SUPPL-64 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/23/1983 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/22/1982 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/22/1978 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/12/1981 | SUPPL-42 | Labeling |
Label is not available on this site. |