Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072721
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOVIA 1/35E-28 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.035MG;1MG TABLET;ORAL-28 Prescription AB 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-36 Labeling-Package Insert

Label is not available on this site.

10/20/2004 SUPPL-15 Labeling

Label is not available on this site.

07/30/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/2001 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

01/29/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/2002 SUPPL-5 Labeling

Label is not available on this site.

04/30/1997 SUPPL-4 Labeling

Label is not available on this site.

04/10/1996 SUPPL-3 Labeling

Label is not available on this site.

09/27/1994 SUPPL-2 Labeling

Label is not available on this site.

08/12/1993 SUPPL-1 Labeling

Label is not available on this site.

ZOVIA 1/35E-28

TABLET;ORAL-28; 0.035MG;1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 204703 MYLAN LABS LTD
KELNOR ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 076785 BARR
LO-MALMOREDE ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 209548 NOVAST LABS
ZOVIA 1/35E-28 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 072721 MAYNE PHARMA

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