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FDA ANDA · ANDA076221
JINTELI
norethindrone acetate and ethinyl estradiol
Sponsor: BARR LABS INC
APPLICATION
ANDA076221
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-06
LATEST ACTION
2024-02-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.005MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL
Approval history
2024-02-15Labeling · Supplement 15 · standardAP
2024-01-29Labeling · Supplement 14 · standardAP
2015-01-07Labeling · Supplement 8 · standardAP
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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