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FDA ANDA · ANDA075863
KARIVA
desogestrel/ethinyl estradiol and ethinyl estradiol
Sponsor: BARR
APPLICATION
ANDA075863
TYPE
ANDA
ORIGINAL APPROVAL
2002-04-05
LATEST ACTION
2024-06-10
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
KARIVAPrescription
DESOGESTREL 0.15MG,N/A, ETHINYL ESTRADIOL 0.02MG,0.01MG · TABLET · ORAL-28
Approval history
2024-06-10Labeling · Supplement 37 · standardAP
2024-06-10Labeling · Supplement 35 · standardAP
2022-04-29Labeling · Supplement 34 · standardAP
2017-08-09Labeling · Supplement 26 · standardAP
2013-02-28Labeling · Supplement 20 · standardAP
2013-02-28Labeling · Supplement 21 · standardAP
2009-09-24Labeling · Supplement 15AP
2002-10-04Manufacturing (CMC) · Supplement 1AP
2002-10-04Manufacturing (CMC) · Supplement 2AP
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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