Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070759
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORETHINDRONE AND MESTRANOL MESTRANOL; NORETHINDRONE 0.05MG;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
07/01/1988 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
06/26/2002 SUPPL-10 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.

10/04/2001 SUPPL-8 Manufacturing (CMC)-Control

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.

07/31/1989 SUPPL-1 Labeling

Label is not available on this site.

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