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FDA ANDA · ANDA076629
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Sponsor: DR REDDYS LABS SA
APPLICATION
ANDA076629
TYPE
ANDA
ORIGINAL APPROVAL
2010-03-18
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLDiscontinued
ETHINYL ESTRADIOL 0.02MG,0.03MG,0.035MG, NORETHINDRONE ACETATE 1MG,1MG,1MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 11 · standardAP
2021-11-09Labeling · Supplement 10 · standardAP
2021-08-06Labeling · Supplement 9 · standardAP
2015-04-13Labeling · Supplement 5AP
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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