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FDA ANDA · ANDA200492
JAIMIESS
levonorgestrel and ethinyl estradiol and ethinyl estradiol tablets
Sponsor: XIROMED
APPLICATION
ANDA200492
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-27
LATEST ACTION
2026-06-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.03MG,0.01MG, LEVONORGESTREL 0.15MG,N/A · TABLET · ORAL
Approval history
2026-06-16Labeling · Supplement 13 · standardAP
2026-06-16Labeling · Supplement 3 · standardAP
2026-06-16Labeling · Supplement 10 · standardAP
2019-01-24Labeling · Supplement 5 · standardAP
2015-05-27Not Applicable · OriginalAP
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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