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FDA ANDA · ANDA206053

ROSYRAH

levonorgestrel and ethinyl estradiol and ethinyl estradiol

Sponsor: XIROMED

APPLICATION
ANDA206053
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-02
LATEST ACTION
2025-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.02MG,0.15MG, LEVONORGESTREL 0.025MG,0.15MG · TABLET · ORAL

Approval history

2025-02-28Labeling · Supplement 7 · standardAP
2025-02-28Labeling · Supplement 4 · standardAP
2017-10-02UNKNOWN · 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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