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FDA ANDA · ANDA091346
VIORELE
desogestrel and ethinyl estradiol and ethinyl estradiol
Sponsor: GLENMARK PHARMS LTD
APPLICATION
ANDA091346
TYPE
ANDA
ORIGINAL APPROVAL
2012-04-02
LATEST ACTION
2024-04-25
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VIORELEPrescription
DESOGESTREL 0.15MG,N/A, ETHINYL ESTRADIOL 0.02MG,0.01MG · TABLET · ORAL-28
Approval history
2024-04-25Manufacturing (CMC) · Supplement 16 · unknownAP
2023-08-25Labeling · Supplement 14 · standardAP
2023-08-25Labeling · Supplement 13 · standardAP
2022-04-29Labeling · Supplement 11 · standardAP
2017-08-09Labeling · Supplement 6 · standardAP
2015-04-13Labeling · Supplement 3 · standardAP
2013-03-28Labeling · Supplement 1 · standardAP
2012-04-02OriginalAP
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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