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FDA ANDA · ANDA206851
SIMPESSE
levonorgestrel and ethinyl estradiol and ethinyl estradiol
Sponsor: AUROBINDO PHARMA
APPLICATION
ANDA206851
TYPE
ANDA
ORIGINAL APPROVAL
2017-04-07
LATEST ACTION
2025-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SIMPESSEPrescription
ETHINYL ESTRADIOL 0.03MG,0.01MG, LEVONORGESTREL 0.15MG,N/A · TABLET · ORAL
Approval history
2025-06-18Labeling · Supplement 4 · standardAP
2023-01-20Labeling · Supplement 2 · standardAP
2023-01-20Labeling · Supplement 3 · standardAP
2023-01-20Labeling · Supplement 1 · standardAP
2017-04-07UNKNOWN · Original · standardAP
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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