Last Updated: November 9, 2026

Details for New Drug Application (NDA): 090033

NDA 090033 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 090033

Tradename:	RIFABUTIN
Applicant:	Lupin
Ingredient:	rifabutin
Patents:	0

Medical Subject Heading (MeSH) Categories for 090033

Anti-Bacterial Agents
Antibiotics, Antitubercular

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	Feb 24, 2014	TE:		RLD:	No

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