Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071481
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORETHIN 1/35E-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 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
04/12/1988 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
07/11/1997 SUPPL-14 Labeling

Label is not available on this site.

01/13/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/13/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/23/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/01/1992 SUPPL-10 Labeling

Label is not available on this site.

08/28/1992 SUPPL-9 Labeling

Label is not available on this site.

10/11/1991 SUPPL-8 Labeling

Label is not available on this site.

10/11/1991 SUPPL-7 Labeling

Label is not available on this site.

09/09/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/24/1991 SUPPL-5 Labeling

Label is not available on this site.

06/19/1991 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/22/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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