Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018128
Company: WARNER CHILCOTT
Company: WARNER CHILCOTT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OVCON-50 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.05MG;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 |
|---|---|---|---|---|---|---|---|
| 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-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/25/1995 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 03/12/1993 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/12/1993 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 05/24/1994 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/21/1992 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 01/02/1991 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/24/1989 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 03/18/1986 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/10/1986 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/01/1984 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/03/1984 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 03/25/1983 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 02/08/1984 | 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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| 01/22/1980 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 07/31/1979 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
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. |