APPLICATION
ANDA203872
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-22
LATEST ACTION
2023-10-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVONORGESTREL AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.03MG,0.01MG, LEVONORGESTREL 0.15MG,N/A · TABLET · ORAL
Approval history
2023-10-04Labeling · Supplement 2 · standardAP
2023-10-04Labeling · Supplement 3 · standardAP
2015-12-22UNKNOWN · 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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