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FDA ANDA · ANDA204057

NORGESTIMATE AND ETHINYL ESTRADIOL

Sponsor: GLENMARK SPECLT

APPLICATION
ANDA204057
TYPE
ANDA
ORIGINAL APPROVAL
2016-02-23
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NORGESTIMATE AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.025MG,0.025MG,0.025MG, NORGESTIMATE 0.18MG,0.215MG,0.25MG · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 5 · standardAP
2022-02-04Labeling · Supplement 1 · standardAP
2016-02-23UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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