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FDA ANDA · ANDA203164

LEVONORGESTREL AND ETHINYL ESTRADIOL

Sponsor: GLENMARK PHARMS LTD

APPLICATION
ANDA203164
TYPE
ANDA
ORIGINAL APPROVAL
2015-06-12
LATEST ACTION
2024-01-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LEVONORGESTREL AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.03MG, LEVONORGESTREL 0.15MG · TABLET · ORAL

Approval history

2024-01-09Labeling · Supplement 6 · standardAP
2024-01-09Labeling · Supplement 4 · standardAP
2021-01-13Labeling · Supplement 2 · standardAP
2021-01-13Labeling · Supplement 1 · standardAP
2015-06-12UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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