Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091325
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription AB1 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
09/19/2011 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
12/28/2012 SUPPL-2 Labeling-Proprietary Name Change

Label is not available on this site.

NORETHINDRONE

TABLET;ORAL-28; 0.35MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CAMILA NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 076177 MAYNE PHARMA
HEATHER NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 090454 GLENMARK GENERICS
INCASSIA NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 207304 AUROBINDO PHARMA LTD
NOR-QD NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription Yes AB1 017060 APIL
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 206807 ACCORD HLTHCARE
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 202260 AMNEAL PHARMS
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 091325 LUPIN LTD
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 201483 MYLAN LABS LTD
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 202014 NOVAST LABS

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