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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206069
Company: AUROBINDO PHARMA LTD

Products on ANDA 206069

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	200MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206069

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/06/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 206069

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; 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

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

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