Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200751
Company: LUPIN

Products on ANDA 200751

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200751

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.

Therapeutic Equivalents for ANDA 200751

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	201514	COREPHARMA
ARMODAFINIL	ARMODAFINIL	50MG	TABLET;ORAL	Prescription	No	AB	200751	LUPIN
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	NUVO PHARMS

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	201514	COREPHARMA
ARMODAFINIL	ARMODAFINIL	150MG	TABLET;ORAL	Prescription	No	AB	200751	LUPIN
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	NUVO PHARMS

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
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	NUVO PHARMS

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	201514	COREPHARMA
ARMODAFINIL	ARMODAFINIL	250MG	TABLET;ORAL	Prescription	No	AB	200751	LUPIN
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	NUVO PHARMS