Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016672
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.

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