Drugs@FDA: FDA-Approved Drugs
Company: WARNER CHILCOTT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OVCON-35 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-21 | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
07/05/1978 | 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 |
---|---|---|---|---|---|
11/14/1997 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/10/1998 | SUPPL-33 | Labeling |
Label is not available on this site. |
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07/07/1995 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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02/14/1995 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/25/1995 | SUPPL-30 | Labeling |
Label is not available on this site. |
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03/12/1993 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/12/1993 | SUPPL-28 | Labeling |
Label is not available on this site. |
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04/08/1994 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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01/25/1995 | SUPPL-25 | Labeling |
Label is not available on this site. |
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07/21/1992 | SUPPL-24 | Labeling |
Label is not available on this site. |
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07/24/1991 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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03/12/1991 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/24/1989 | SUPPL-20 | Labeling |
Label is not available on this site. |
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03/18/1986 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/01/1984 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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12/03/1984 | SUPPL-14 | Labeling |
Label is not available on this site. |
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01/23/1984 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/25/1983 | SUPPL-12 | Labeling |
Label is not available on this site. |
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02/08/1983 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/05/1982 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/14/1981 | SUPPL-8 | Labeling |
Label is not available on this site. |
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01/14/1980 | SUPPL-5 | Labeling |
Label is not available on this site. |
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08/29/1979 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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06/04/1979 | SUPPL-3 | Labeling |
Label is not available on this site. |
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01/19/1979 | SUPPL-1 | Labeling |
Label is not available on this site. |