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FDA ANDA · ANDA076455
VELIVET TRIPHASIC REGIMEN
desogestrel and ethinyl estradiol
Sponsor: DURAMED PHARMS BARR
APPLICATION
ANDA076455
TYPE
ANDA
ORIGINAL APPROVAL
2004-02-24
LATEST ACTION
2011-07-14
ROUTE
Oral, ORAL-28
DOSAGE FORM
Tablet, TABLET
MARKETING STATUS
Prescription
Products
DESOGESTREL; ETHINYLPrescription
DESOGESTREL 0.15MG/0.025MG, ETHINYL ESTRADIOL · Tablet · Oral
VELIVETPrescription
DESOGESTREL 0.1MG,0.125MG,0.15MG, ETHINYL ESTRADIOL 0.025MG,0.025MG,0.025MG · TABLET · ORAL-28
DESOGESTREL; ETHINYLPrescription
DESOGESTREL 0.125MG/0.025MG, ETHINYL ESTRADIOL · Tablet · Oral
Approval history
2011-07-14Labeling · Supplement 11AP
2004-02-24OriginalAP
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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