Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076785
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KELNOR ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.035MG;1MG 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
05/23/2005 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-15 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

KELNOR

TABLET;ORAL-28; 0.035MG;1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 204703 MYLAN LABS LTD
KELNOR ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 076785 BARR
ZOVIA 1/35E-28 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 072721 MAYNE PHARMA

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