Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200980
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription AB2 No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/12/2013 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/24/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

NORETHINDRONE

TABLET;ORAL-28; 0.35MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ERRIN NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB2 076225 MAYNE PHARMA
JENCYCLA NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB2 091323 LUPIN LTD
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB2 091209 GLENMARK GENERICS
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB2 200980 MYLAN LABS LTD
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB2 200961 NOVAST LABS

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