Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077667
Company: APOTEX

Products on ANDA 077667

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077667

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/03/2014	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
06/21/2023	SUPPL-10	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/11/2021	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
05/11/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077667

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
MODAFINIL	MODAFINIL	100MG	TABLET;ORAL	Prescription	No	AB	077667	APOTEX
MODAFINIL	MODAFINIL	100MG	TABLET;ORAL	Prescription	No	AB	207196	APPCO
MODAFINIL	MODAFINIL	100MG	TABLET;ORAL	Prescription	No	AB	202566	AUROBINDO PHARMA LTD
MODAFINIL	MODAFINIL	100MG	TABLET;ORAL	Prescription	No	AB	209966	CADILA
MODAFINIL	MODAFINIL	100MG	TABLET;ORAL	Prescription	No	AB	078963	ORBION PHARMS
PROVIGIL	MODAFINIL	100MG	TABLET;ORAL	Prescription	Yes	AB	020717	NUVO PHARMS

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
MODAFINIL	MODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	077667	APOTEX
MODAFINIL	MODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	207196	APPCO
MODAFINIL	MODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	202566	AUROBINDO PHARMA LTD
MODAFINIL	MODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	209966	CADILA
MODAFINIL	MODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	078963	ORBION PHARMS
PROVIGIL	MODAFINIL	200MG	TABLET;ORAL	Prescription	Yes	AB	020717	NUVO PHARMS