Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071043
Company: WATSON LABS

Products on ANDA 071043

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG;0.5MG,1MG	TABLET;ORAL-21	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071043

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/01/1988	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-28	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/09/2017	SUPPL-27	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/05/2002	SUPPL-13	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
11/05/2002	SUPPL-12	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
06/26/2002	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
05/21/2002	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
01/10/2002	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
10/31/2001	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
05/08/2002	SUPPL-6	Labeling		Label is not available on this site.
05/01/1997	SUPPL-5	Labeling		Label is not available on this site.
11/04/1993	SUPPL-4	Labeling		Label is not available on this site.
08/10/1993	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/15/1990	SUPPL-2	Labeling		Label is not available on this site.