Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076238
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BALZIVA-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET;ORAL-28 Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/22/2004 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

BALZIVA-28

TABLET;ORAL-28; 0.035MG;0.4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BALZIVA-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET;ORAL-28 Prescription No AB 076238 BARR
BRIELLYN ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET;ORAL-28 Prescription No AB 090538 GLENMARK GENERICS
GILDAGIA ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET;ORAL-28 Prescription No AB 078376 VINTAGE PHARMS
NORETHINDRONE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET;ORAL-28 Prescription No AB 200897 MYLAN LABS LTD
NORETHINDRONE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET;ORAL-28 Prescription No AB 078323 WATSON LABS
PHILITH ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET;ORAL-28 Prescription No AB 090947 NOVAST LABS LTD
VYFEMLA ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET;ORAL-28 Prescription No AB 201886 LUPIN LTD

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