Drugs@FDA: FDA-Approved Drugs
Company: WARNER CHILCOTT LLC
| 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ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-28 | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/29/1976 | 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 |
|---|---|---|---|---|---|
| 12/21/1998 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/14/1997 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/10/1998 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 07/07/1995 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/25/1995 | SUPPL-43 | Labeling |
Label is not available on this site. |
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| 03/12/1993 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/08/1994 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/12/1993 | SUPPL-39 | Labeling |
Label is not available on this site. |
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| 02/14/1995 | SUPPL-38 | Labeling |
Label is not available on this site. |
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| 07/21/1992 | SUPPL-37 | Labeling |
Label is not available on this site. |
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| 07/24/1991 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1991 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/24/1989 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 03/18/1986 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/27/1984 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/03/1984 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 01/23/1984 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/25/1983 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 02/08/1984 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/05/1982 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/14/1981 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 01/14/1980 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 08/28/1979 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/04/1979 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 01/19/1979 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/20/1978 | SUPPL-14 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 06/08/1978 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1978 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/18/1978 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/1978 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/28/1978 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 07/14/1978 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 04/28/1978 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 04/30/1976 | SUPPL-1 | Labeling |
Label is not available on this site. |