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. |
||
08/08/1990 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
07/15/1986 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
02/19/1986 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/16/1985 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
01/07/1986 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
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. |
||
02/19/1985 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/21/1980 | SUPPL-28 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
11/22/1977 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
12/07/1978 | SUPPL-19 | Labeling |
Label is not available on this site. |