Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202741
Company: MYLAN LABS LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG 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
02/20/2015 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
11/08/2018 SUPPL-3 Labeling-Proprietary Name Change

Label is not available on this site.
11/08/2018 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.03MG;1.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AUROVELA FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-28 Prescription No AB 207580 AUROBINDO PHARMA LTD
BLISOVI FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-28 Prescription No AB 201585 LUPIN LTD
GILDESS FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-28 Prescription No AB 077075 VINTAGE PHARMS LLC
HAILEY FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-28 Prescription No AB 209031 GLENMARK PHARMS
JUNEL FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-28 Prescription No AB 076064 BARR
LARIN FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-28 Prescription No AB 091453 NOVAST LABS
MICROGESTIN FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-28 Prescription No AB 075548 MAYNE PHARMA
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-28 Prescription No AB 202741 MYLAN LABS LTD

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