Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071041
Company: WATSON LABS TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORETHINDRONE AND ETHINYL ESTRADIOL (7/14) 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
09/24/1991 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-4 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

05/21/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

05/01/1997 SUPPL-2 Labeling

Label is not available on this site.

08/10/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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