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FDA ANDA · ANDA076785
KELNOR 1/35
ethynodiol diacetate and ethinyl estradiol
Sponsor: BARR
APPLICATION
ANDA076785
TYPE
ANDA
ORIGINAL APPROVAL
2005-05-23
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
KELNORPrescription
ETHINYL ESTRADIOL 0.035MG, ETHYNODIOL DIACETATE 1MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 20 · standardAP
2017-08-09Labeling · Supplement 15 · standardAP
2005-05-23OriginalAP
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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