Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207580
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AUROVELA FE 1.5/30 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
06/15/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

AUROVELA FE 1.5/30

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
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 LTD
LOESTRIN FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-28 Prescription Yes AB 017355 APIL
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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