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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016806
Company: WYETH PHARMS

Products on NDA 016806

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016806

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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