Drugs@FDA: FDA-Approved Drugs
Company: GD SEARLE LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OVULEN | ETHYNODIOL DIACETATE; MESTRANOL | 1MG;0.1MG | TABLET;ORAL-20 | Discontinued | None | No | No |
OVULEN-21 | ETHYNODIOL DIACETATE; MESTRANOL | 1MG;0.1MG | 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 |
---|---|---|---|---|---|---|---|
03/23/1966 | 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-65 | Labeling |
Label is not available on this site. |
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06/10/1986 | SUPPL-64 | Labeling |
Label is not available on this site. |
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03/13/1986 | SUPPL-63 | Labeling |
Label is not available on this site. |
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06/05/1985 | SUPPL-62 | Labeling |
Label is not available on this site. |
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04/05/1985 | SUPPL-61 | Labeling |
Label is not available on this site. |
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02/12/1985 | SUPPL-60 | Labeling |
Label is not available on this site. |
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09/18/1984 | SUPPL-59 | Labeling |
Label is not available on this site. |
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03/06/1984 | SUPPL-57 | Labeling |
Label is not available on this site. |
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06/03/1983 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/09/1983 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/22/1982 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/16/1979 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/03/1981 | SUPPL-35 | Labeling |
Label is not available on this site. |