Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076594
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription AB No No
MODAFINIL MODAFINIL 200MG 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
07/16/2012 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
12/01/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

10/20/2014 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

MODAFINIL

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 202700 ALEMBIC PHARMS LTD
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 077667 APOTEX INC
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 202566 AUROBINDO PHARMA LTD
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 207196 HERITAGE PHARMS INC
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 090543 HIKMA PHARMS
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 076594 MYLAN PHARMS INC
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 078963 ORCHID HLTHCARE
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 076715 WATSON LABS INC
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 209966 ZYDUS PHARMS USA INC
PROVIGIL MODAFINIL 100MG TABLET;ORAL Prescription Yes AB 020717 CEPHALON

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 202700 ALEMBIC PHARMS LTD
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 077667 APOTEX INC
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 202566 AUROBINDO PHARMA LTD
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 207196 HERITAGE PHARMS INC
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 090543 HIKMA PHARMS
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 076594 MYLAN PHARMS INC
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 078963 ORCHID HLTHCARE
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 076715 WATSON LABS INC
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 209966 ZYDUS PHARMS USA INC
PROVIGIL MODAFINIL 200MG TABLET;ORAL Prescription Yes AB 020717 CEPHALON

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