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FDA ANDA · ANDA202635

LEADER EMERGENCY CONTRACEPTIVE LEVONORGESTREL

levonorgestrel

Sponsor: SUN PHARM

APPLICATION
ANDA202635
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-11
LATEST ACTION
2016-05-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

OPCICON ONE-STEPOver-the-counter
LEVONORGESTREL 1.5MG · TABLET · ORAL

Approval history

2016-05-29Labeling · Supplement 1 · standardAP
2014-09-11UNKNOWN · 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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