Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016029
Company: GD SEARLE LLC

Products on NDA 016029

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OVULEN	ETHYNODIOL DIACETATE; MESTRANOL	1MG;0.1MG	TABLET;ORAL-20	Discontinued	None	No	No
OVULEN-21	ETHYNODIOL DIACETATE; MESTRANOL	1MG;0.1MG	TABLET;ORAL-21	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016029

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/23/1966	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	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
10/23/1986	SUPPL-65	Labeling		Label is not available on this site.
06/10/1986	SUPPL-64	Labeling		Label is not available on this site.
03/13/1986	SUPPL-63	Labeling		Label is not available on this site.
06/05/1985	SUPPL-62	Labeling		Label is not available on this site.
04/05/1985	SUPPL-61	Labeling		Label is not available on this site.
02/12/1985	SUPPL-60	Labeling		Label is not available on this site.
09/18/1984	SUPPL-59	Labeling		Label is not available on this site.
03/06/1984	SUPPL-57	Labeling		Label is not available on this site.
06/03/1983	SUPPL-55	Manufacturing (CMC)-Control		Label is not available on this site.
06/09/1983	SUPPL-54	Manufacturing (CMC)-Control		Label is not available on this site.
11/22/1982	SUPPL-52	Manufacturing (CMC)-Control		Label is not available on this site.
05/16/1979	SUPPL-49	Manufacturing (CMC)-Control		Label is not available on this site.
03/03/1981	SUPPL-35	Labeling		Label is not available on this site.