Drugs@FDA: FDA-Approved Drugs
Company: WARNER CHILCOTT LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OVCON-50 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.05MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-28 | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
08/28/1975 | 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 |
---|---|---|---|---|---|
07/22/2008 | SUPPL-51 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017576s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017576s051ltr.pdf | |
12/21/1998 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
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11/14/1997 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/05/1997 | SUPPL-46 | Labeling |
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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02/14/1995 | SUPPL-43 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/25/1995 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
03/12/1993 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/12/1993 | SUPPL-40 | Labeling |
Label is not available on this site. |
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05/24/1994 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/21/1992 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
01/02/1991 | 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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01/10/1986 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/27/1984 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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12/03/1984 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
03/25/1983 | SUPPL-25 | Labeling |
Label is not available on this site. |
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02/08/1984 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/14/1981 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
01/22/1980 | SUPPL-18 | Labeling |
Label is not available on this site. |
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07/31/1979 | SUPPL-17 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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06/04/1979 | SUPPL-16 | Labeling |
Label is not available on this site. |
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01/23/1979 | SUPPL-14 | Labeling |
Label is not available on this site. |
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10/20/1978 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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06/08/1978 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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07/14/1978 | SUPPL-11 | Labeling |
Label is not available on this site. |
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10/18/1978 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/12/1979 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/28/1978 | SUPPL-8 | Labeling |
Label is not available on this site. |
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07/14/1978 | SUPPL-7 | 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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05/03/1976 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/22/2008 | SUPPL-51 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017576s051lbl.pdf |