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FDA ANDA · ANDA090716

SETLAKIN

levonorgestrel and ethinyl estradiol

Sponsor: NOVAST LABS

APPLICATION
ANDA090716
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-15
LATEST ACTION
2025-06-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SETLAKINPrescription
ETHINYL ESTRADIOL 0.03MG, LEVONORGESTREL 0.15MG · TABLET · ORAL

Approval history

2025-06-17Labeling · Supplement 9 · standardAP
2025-06-17Labeling · Supplement 3 · standardAP
2025-06-17Labeling · Supplement 8 · standardAP
2014-09-15OriginalAP
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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