APPLICATION
ANDA201512
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-24
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PIRMELLA 1/35Discontinued
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 1MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 13 · standardAP
2019-04-29Manufacturing (CMC) · Supplement 11 · unknownAP
2019-03-22Labeling · Supplement 8 · standardAP
2016-08-22Labeling · Supplement 5 · standardAP
2015-04-13Labeling · Supplement 4 · standardAP
2013-04-24Not Applicable · OriginalAP
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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