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FDA ANDA · ANDA079102
ALTAVERA
levonorgestrel and ethinyl estradiol
Sponsor: XIROMED
APPLICATION
ANDA079102
TYPE
ANDA
ORIGINAL APPROVAL
2010-08-03
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ALTAVERAPrescription
ETHINYL ESTRADIOL 0.03MG, LEVONORGESTREL 0.15MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 12 · standardAP
2022-03-04Labeling · Supplement 10 · standardAP
2020-03-03Labeling · Supplement 9 · standardAP
2017-08-09Labeling · Supplement 8 · standardAP
2014-02-25Labeling · Supplement 6 · standardAP
2011-05-24Labeling · Supplement 2AP
2010-08-03OriginalAP
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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