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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200751
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARMODAFINIL ARMODAFINIL 50MG TABLET;ORAL Prescription AB No No
ARMODAFINIL ARMODAFINIL 100MG TABLET; ORAL None (Tentative Approval) None No No
ARMODAFINIL ARMODAFINIL 150MG TABLET;ORAL Prescription AB No No
ARMODAFINIL ARMODAFINIL 200MG TABLET;ORAL Prescription AB No No
ARMODAFINIL ARMODAFINIL 250MG TABLET;ORAL 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
11/28/2016 ORIG-2 Tentative Approval Not Applicable

Label is not available on this site.

11/28/2016 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
07/14/2017 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

07/14/2017 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

ARMODAFINIL

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARMODAFINIL ARMODAFINIL 50MG TABLET;ORAL Prescription No AB 206069 AUROBINDO PHARMA LTD
ARMODAFINIL ARMODAFINIL 50MG TABLET;ORAL Prescription No AB 200751 LUPIN LTD
ARMODAFINIL ARMODAFINIL 50MG TABLET;ORAL Prescription No AB 200043 MYLAN PHARMS INC
ARMODAFINIL ARMODAFINIL 50MG TABLET;ORAL Prescription No AB 202768 NATCO PHARMA LTD
NUVIGIL ARMODAFINIL 50MG TABLET;ORAL Prescription Yes AB 021875 CEPHALON

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARMODAFINIL ARMODAFINIL 150MG TABLET;ORAL Prescription No AB 206069 AUROBINDO PHARMA LTD
ARMODAFINIL ARMODAFINIL 150MG TABLET;ORAL Prescription No AB 200751 LUPIN LTD
ARMODAFINIL ARMODAFINIL 150MG TABLET;ORAL Prescription No AB 200043 MYLAN PHARMS INC
ARMODAFINIL ARMODAFINIL 150MG TABLET;ORAL Prescription No AB 202768 NATCO PHARMA LTD
NUVIGIL ARMODAFINIL 150MG TABLET;ORAL Prescription Yes AB 021875 CEPHALON

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARMODAFINIL ARMODAFINIL 200MG TABLET;ORAL Prescription No AB 206069 AUROBINDO PHARMA LTD
ARMODAFINIL ARMODAFINIL 200MG TABLET;ORAL Prescription No AB 200751 LUPIN LTD
ARMODAFINIL ARMODAFINIL 200MG TABLET;ORAL Prescription No AB 200043 MYLAN PHARMS INC
ARMODAFINIL ARMODAFINIL 200MG TABLET;ORAL Prescription No AB 202768 NATCO PHARMA LTD
NUVIGIL ARMODAFINIL 200MG TABLET;ORAL Prescription Yes AB 021875 CEPHALON

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARMODAFINIL ARMODAFINIL 250MG TABLET;ORAL Prescription No AB 206069 AUROBINDO PHARMA LTD
ARMODAFINIL ARMODAFINIL 250MG TABLET;ORAL Prescription No AB 200751 LUPIN LTD
ARMODAFINIL ARMODAFINIL 250MG TABLET;ORAL Prescription No AB 200043 MYLAN PHARMS INC
ARMODAFINIL ARMODAFINIL 250MG TABLET;ORAL Prescription No AB 202768 NATCO PHARMA LTD
NUVIGIL ARMODAFINIL 250MG TABLET;ORAL Prescription Yes AB 021875 CEPHALON
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