Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016806
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.

07/08/1998 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

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.

01/28/1994 SUPPL-26 Labeling

Label is not available on this site.

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.

08/08/1990 SUPPL-23 Labeling

Label is not available on this site.

07/15/1986 SUPPL-21 Labeling

Label is not available on this site.

02/19/1986 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/1985 SUPPL-19 Labeling

Label is not available on this site.

09/04/1984 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/26/1984 SUPPL-17 Labeling

Label is not available on this site.

02/28/1985 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/22/1977 SUPPL-14 Labeling

Label is not available on this site.

10/20/1978 SUPPL-10 Labeling

Label is not available on this site.

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