Drugs@FDA: FDA-Approved Drugs
Company: WYETH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OVRAL | ETHINYL ESTRADIOL; NORGESTREL | 0.05MG;0.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/16/1968 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | PRIORITY |
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-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1998 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1997 | SUPPL-47 | 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-46 | 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-45 | Labeling |
Label is not available on this site. |
||
| 01/28/1994 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 12/23/1993 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1989 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/27/1988 | SUPPL-41 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 08/08/1990 | SUPPL-40 | Labeling |
Label is not available on this site. |
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| 07/15/1986 | SUPPL-38 | Labeling |
Label is not available on this site. |
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| 02/19/1986 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/16/1985 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 01/07/1986 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/19/1988 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1984 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 02/19/1985 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/21/1980 | SUPPL-28 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 11/22/1977 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 12/07/1978 | SUPPL-19 | Labeling |
Label is not available on this site. |