Last Updated: November 9, 2026

Details for New Drug Application (NDA): 219519

NDA 219519 describes RIFABUTIN, which is a drug marketed by Lupin, Novitium Pharma, Pharmazone, and Zydus Lifesciences, and is included in four NDAs. It is available from four suppliers. Additional details are available on the RIFABUTIN profile page.

The generic ingredient in RIFABUTIN is rifabutin. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the rifabutin profile page.

Summary for 219519

Tradename:	RIFABUTIN
Applicant:	Zydus Lifesciences
Ingredient:	rifabutin
Patents:	0

Medical Subject Heading (MeSH) Categories for 219519

Anti-Bacterial Agents
Antibiotics, Antitubercular

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	Aug 21, 2026	TE:	AB	RLD:	No

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