Drugs@FDA: FDA-Approved Drugs
Company: WYETH PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OVRAL-28 | ETHINYL ESTRADIOL; NORGESTREL | 0.05MG;0.5MG | 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 |
---|---|---|---|---|---|---|---|
11/26/1968 | 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 |
---|---|---|---|---|---|
03/06/2002 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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07/08/1998 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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08/14/1997 | SUPPL-29 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/16672-s047_ovral_ovral-28.pdf |
03/23/2001 | SUPPL-28 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16672S46LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/16-672S046_16806s028.pdf |
11/29/1994 | SUPPL-27 | Labeling |
Label is not available on this site. |
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01/28/1994 | SUPPL-26 | Labeling |
Label is not available on this site. |
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12/23/1993 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/27/1988 | SUPPL-24 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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08/08/1990 | SUPPL-23 | Labeling |
Label is not available on this site. |
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07/15/1986 | SUPPL-21 | Labeling |
Label is not available on this site. |
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02/19/1986 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/16/1985 | SUPPL-19 | Labeling |
Label is not available on this site. |
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09/04/1984 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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07/26/1984 | SUPPL-17 | Labeling |
Label is not available on this site. |
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02/28/1985 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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11/22/1977 | SUPPL-14 | Labeling |
Label is not available on this site. |
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10/20/1978 | SUPPL-10 | Labeling |
Label is not available on this site. |