Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072722
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOVIA 1/50E-21 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.05MG;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
12/30/1991 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-26 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

07/30/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/2001 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

01/29/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/2002 SUPPL-6 Labeling

Label is not available on this site.

04/30/1997 SUPPL-5 Labeling

Label is not available on this site.

04/10/1996 SUPPL-4 Labeling

Label is not available on this site.

09/27/1994 SUPPL-3 Labeling

Label is not available on this site.

08/12/1993 SUPPL-2 Labeling

Label is not available on this site.

05/17/1993 SUPPL-1 Labeling

Label is not available on this site.

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