Drugs@FDA: FDA Approved Drug Products

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

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