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FDA ANDA · ANDA079064

INTROVALE

levonorgestrel and ethinyl estradiol

Sponsor: XIROMED

APPLICATION
ANDA079064
TYPE
ANDA
ORIGINAL APPROVAL
2010-09-27
LATEST ACTION
2026-06-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2026-06-25Labeling · Supplement 7 · standardAP
2026-06-25Labeling · Supplement 10 · standardAP
2026-06-25Labeling · Supplement 8 · standardAP
2026-06-25Labeling · Supplement 11 · standardAP
2011-05-18Labeling · Supplement 2AP
2010-09-27OriginalAP
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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