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FDA ANDA · ANDA200494
NORGESTIMATE AND ETHINYL ESTRADIOL
Sponsor: GLENMARK PHARMS LTD
APPLICATION
ANDA200494
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-17
LATEST ACTION
2023-02-22
ROUTE
ORAL, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NORGESTIMATE; ETHINYL ESTRADIOLPrescription
NORGESTIMATE 0.215MG, ETHINYL ESTRADIOL 0.035MG · TABLET · ORAL
NORGESTIMATE; ETHINYL ESTRADIOLPrescription
NORGESTIMATE 0.25MG, ETHINYL ESTRADIOL 0.035MG · TABLET · ORAL
NORGESTIMATE AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORGESTIMATE 0.18MG,0.215MG,0.25MG · TABLET · ORAL-28
Approval history
2023-02-22Labeling · Supplement 15 · standardAP
2022-04-29Labeling · Supplement 14 · standardAP
2022-01-26Labeling · Supplement 9 · standardAP
2022-01-26Labeling · Supplement 7 · standardAP
2015-04-28Labeling · Supplement 6 · standardAP
2013-03-28Labeling · Supplement 5 · standardAP
2012-06-28Labeling · Supplement 2AP
2011-06-17Not 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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