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FDA ANDA · ANDA206852

LO SIMPESSE

levonorgestrel and ethinyl estradiol and ethinyl estradiol

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA206852
TYPE
ANDA
ORIGINAL APPROVAL
2017-04-28
LATEST ACTION
2025-06-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LO SIMPESSEPrescription
ETHINYL ESTRADIOL 0.02MG,0.1MG, LEVONORGESTREL 0.01MG,N/A · TABLET · ORAL

Approval history

2025-06-20Labeling · Supplement 3 · standardAP
2017-04-28UNKNOWN · Original · standardAP
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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