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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202772
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 0.02MG;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
11/14/2013 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; 0.02MG;1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AUROVELA FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 207505 AUROBINDO PHARMA LTD
BLISOVI FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 201584 LUPIN LTD
HAILEY FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 206597 GLENMARK PHARMS LTD
JUNEL FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 076081 BARR
LARIN FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 091454 NOVAST LABS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 202772 MYLAN LABS LTD
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