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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217990
Company: LUPIN LTD

Products on ANDA 217990

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RALTEGRAVIR POTASSIUM	RALTEGRAVIR POTASSIUM	EQ 600MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217990

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/06/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217990

RALTEGRAVIR POTASSIUM

TABLET;ORAL; EQ 600MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISENTRESS HD	RALTEGRAVIR POTASSIUM	EQ 600MG BASE	TABLET;ORAL	Prescription	Yes	AB	022145	MSD SUB MERCK
RALTEGRAVIR POTASSIUM	RALTEGRAVIR POTASSIUM	EQ 600MG BASE	TABLET;ORAL	Prescription	No	AB	217990	LUPIN LTD

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