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FDA ANDA · ANDA200538
NORGESTIMATE AND ETHINYL ESTRADIOL
Sponsor: GLENMARK PHARMS LTD
APPLICATION
ANDA200538
TYPE
ANDA
ORIGINAL APPROVAL
2012-04-05
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NORGESTIMATE AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.035MG, NORGESTIMATE 0.25MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 12 · standardAP
2022-01-28Labeling · Supplement 7 · standardAP
2022-01-28Labeling · Supplement 5 · standardAP
2015-04-28Labeling · Supplement 3 · standardAP
2013-03-28Labeling · Supplement 2 · standardAP
2012-04-05Not 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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