APPLICATION
ANDA072720
TYPE
ANDA
ORIGINAL APPROVAL
1991-12-30
LATEST ACTION
2022-04-29
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ZOVIA 1/35E-21Discontinued
ETHINYL ESTRADIOL 0.035MG, ETHYNODIOL DIACETATE 1MG · TABLET · ORAL-21
Approval history
2022-04-29Labeling · Supplement 27 · standardAP
2017-08-09Labeling · Supplement 26 · standardAP
2002-10-18Manufacturing (CMC) · Supplement 10AP
2002-09-11Labeling · Supplement 6AP
2002-07-30Manufacturing (CMC) · Supplement 11AP
2001-10-09Manufacturing (CMC) · Supplement 9AP
2001-01-29Manufacturing (CMC) · Supplement 7AP
1997-04-30Labeling · Supplement 5AP
1996-04-10Labeling · Supplement 4AP
1994-09-27Labeling · Supplement 3AP
1993-08-12Labeling · Supplement 2AP
1993-05-17Labeling · Supplement 1AP
1991-12-30OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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