APPLICATION
ANDA075548
TYPE
ANDA
ORIGINAL APPROVAL
2001-02-05
LATEST ACTION
2021-08-31
ROUTE
ORAL-21, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MICROGESTIN 1.5/30Discontinued
ETHINYL ESTRADIOL 0.03MG, NORETHINDRONE ACETATE 1.5MG · TABLET · ORAL-21
MICROGESTIN FE 1.5/30Discontinued
ETHINYL ESTRADIOL 0.03MG, NORETHINDRONE ACETATE 1.5MG · TABLET · ORAL-28
Approval history
2021-08-31Labeling · Supplement 23 · standardAP
2003-07-30Labeling · Supplement 4AP
2002-11-07Manufacturing (CMC) · Supplement 3AP
2002-07-23Manufacturing (CMC) · Supplement 2AP
2001-10-24Manufacturing (CMC) · Supplement 1AP
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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