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FDA ANDA · ANDA203371
GALBRIELA
norethindrone and ethinyl estradiol and ferrous fumarate
Sponsor: XIROMED
APPLICATION
ANDA203371
TYPE
ANDA
ORIGINAL APPROVAL
2014-04-23
LATEST ACTION
2014-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription
Products
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEPrescription
ETHINYL ESTRADIOL 0.025MG, NORETHINDRONE 0.8MG · TABLET, CHEWABLE · ORAL
Approval history
2014-04-23UNKNOWN · OriginalAP
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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