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FDA ANDA · ANDA200490
INTROVALE
levonorgestrel and ethinyl estradiol tablets
Sponsor: XIROMED
APPLICATION
ANDA200490
TYPE
ANDA
ORIGINAL APPROVAL
2015-04-21
LATEST ACTION
2023-11-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVONORGESTREL AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.03MG, LEVONORGESTREL 0.15MG · TABLET · ORAL
Approval history
2023-11-18Labeling · Supplement 13 · standardAP
2023-11-18Labeling · Supplement 10 · standardAP
2019-02-28Labeling · Supplement 4 · standardAP
2019-02-28Labeling · Supplement 3 · standardAP
2015-04-21Not 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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