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FDA ANDA · ANDA203038

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Sponsor: GLENMARK PHARMS LTD

APPLICATION
ANDA203038
TYPE
ANDA
ORIGINAL APPROVAL
2015-04-02
LATEST ACTION
2024-02-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.005MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.0025MG, NORETHINDRONE ACETATE 0.5MG · TABLET · ORAL

Approval history

2024-02-16Labeling · Supplement 8 · standardAP
2024-01-26Labeling · Supplement 6 · standardAP
2021-01-13Labeling · Supplement 1 · standardAP
2015-04-02UNKNOWN · 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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