Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207210
Company: MACLEODS PHARMS LTD

Products on ANDA 207210

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENTACAPONE	ENTACAPONE	200MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207210

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207210Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 207210

ENTACAPONE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COMTAN	ENTACAPONE	200MG	TABLET;ORAL	Prescription	Yes	AB	020796	ORION PHARMA
ENTACAPONE	ENTACAPONE	200MG	TABLET;ORAL	Prescription	No	AB	205792	AJANTA PHARMA LTD
ENTACAPONE	ENTACAPONE	200MG	TABLET;ORAL	Prescription	No	AB	212601	ALEMBIC
ENTACAPONE	ENTACAPONE	200MG	TABLET;ORAL	Prescription	No	AB	203437	AUROBINDO PHARMA LTD
ENTACAPONE	ENTACAPONE	200MG	TABLET;ORAL	Prescription	No	AB	207210	MACLEODS PHARMS LTD
ENTACAPONE	ENTACAPONE	200MG	TABLET;ORAL	Prescription	No	AB	090690	SUN PHARM
ENTACAPONE	ENTACAPONE	200MG	TABLET;ORAL	Prescription	No	AB	206669	SUNSHINE
ENTACAPONE	ENTACAPONE	200MG	TABLET;ORAL	Prescription	No	AB	078941	WOCKHARDT BIO AG