Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200043
Company: MYLAN PHARMS INC
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 150MG TABLET;ORAL Prescription AB No No
ARMODAFINIL ARMODAFINIL 250MG TABLET;ORAL Prescription AB No No
ARMODAFINIL ARMODAFINIL 100MG TABLET; ORAL None (Tentative Approval) None No No
ARMODAFINIL ARMODAFINIL 200MG TABLET; ORAL None (Tentative Approval) None 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
06/01/2012 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200043s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/20/2016 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/20/2016 SUPPL-1 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 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 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; 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 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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