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FDA ANDA · ANDA203770

JAIMIESS

levonorgestrel / ethinyl estradiol and ethinyl estradiol

Sponsor: XIROMED

APPLICATION
ANDA203770
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-27
LATEST ACTION
2023-11-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

JAIMIESSPrescription
ETHINYL ESTRADIOL 0.03MG,0.01MG, LEVONORGESTREL 0.15MG,N/A · TABLET · ORAL

Approval history

2023-11-16Labeling · Supplement 4 · standardAP
2023-11-16Labeling · Supplement 5 · standardAP
2017-12-27UNKNOWN · Original · standardAP
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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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