Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016705
Company: GD SEARLE LLC
Company: GD SEARLE LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OVULEN-28 | ETHYNODIOL DIACETATE; MESTRANOL | 1MG;0.1MG | TABLET;ORAL-28 | 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 |
---|---|---|---|---|---|---|---|
10/02/1967 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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-42 | Labeling |
Label is not available on this site. |
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06/10/1986 | SUPPL-41 | Labeling |
Label is not available on this site. |
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03/13/1986 | SUPPL-40 | Labeling |
Label is not available on this site. |
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06/05/1985 | SUPPL-39 | Labeling |
Label is not available on this site. |
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04/05/1985 | SUPPL-38 | Labeling |
Label is not available on this site. |
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02/12/1985 | SUPPL-37 | Labeling |
Label is not available on this site. |
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09/18/1984 | SUPPL-36 | Labeling |
Label is not available on this site. |
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03/06/1984 | SUPPL-34 | Labeling |
Label is not available on this site. |
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03/05/1981 | SUPPL-20 | Labeling |
Label is not available on this site. |