Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203540
Company: HETERO LABS LTD III

Products on ANDA 203540

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RALTEGRAVIR POTASSIUM	RALTEGRAVIR POTASSIUM	EQ 400MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203540

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2024	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/203540Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 203540

RALTEGRAVIR POTASSIUM

TABLET;ORAL; EQ 400MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISENTRESS	RALTEGRAVIR POTASSIUM	EQ 400MG BASE	TABLET;ORAL	Prescription	Yes	AB	022145	MSD SUB MERCK
RALTEGRAVIR POTASSIUM	RALTEGRAVIR POTASSIUM	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	203540	HETERO LABS LTD III