Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203347
Company: HETERO LABS LTD III

Products on ANDA 203347

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MARAVIROC	MARAVIROC	150MG	TABLET;ORAL	Prescription	AB	No	No
MARAVIROC	MARAVIROC	300MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203347

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/07/2022	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203347Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 203347

MARAVIROC

TABLET;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MARAVIROC	MARAVIROC	150MG	TABLET;ORAL	Prescription	No	AB	203347	HETERO LABS LTD III
MARAVIROC	MARAVIROC	150MG	TABLET;ORAL	Prescription	No	AB	217114	I 3 PHARMS
MARAVIROC	MARAVIROC	150MG	TABLET;ORAL	Prescription	No	AB	217880	NAVINTA LLC
MARAVIROC	MARAVIROC	150MG	TABLET;ORAL	Prescription	No	AB	216143	RHODES PHARMS
SELZENTRY	MARAVIROC	150MG	TABLET;ORAL	Prescription	Yes	AB	022128	VIIV HLTHCARE

TABLET;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MARAVIROC	MARAVIROC	300MG	TABLET;ORAL	Prescription	No	AB	203347	HETERO LABS LTD III
MARAVIROC	MARAVIROC	300MG	TABLET;ORAL	Prescription	No	AB	217114	I 3 PHARMS
MARAVIROC	MARAVIROC	300MG	TABLET;ORAL	Prescription	No	AB	217880	NAVINTA LLC
MARAVIROC	MARAVIROC	300MG	TABLET;ORAL	Prescription	No	AB	216143	RHODES PHARMS
SELZENTRY	MARAVIROC	300MG	TABLET;ORAL	Prescription	Yes	AB	022128	VIIV HLTHCARE