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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 065421

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NDA 065421 describes RIFAMPIN, which is a drug marketed by Chartwell Molecular, Epic Pharma Llc, Hikma, Lupin Pharms, Avet Lifesciences, Fresenius Kabi Usa, Hikma Pharms, Mylan Labs Ltd, Watson Pharms Teva, and Hikma Intl Pharms, and is included in twelve NDAs. It is available from twelve suppliers. Additional details are available on the RIFAMPIN profile page.

The generic ingredient in RIFAMPIN is isoniazid; rifampin. There are five drug master file entries for this compound. Additional details are available on the isoniazid; rifampin profile page.

Summary for 065421

Tradename:	RIFAMPIN
Applicant:	Mylan Labs Ltd
Ingredient:	rifampin
Patents:	0

Pharmacology for NDA: 065421

Medical Subject Heading (MeSH) Categories for 065421

Antibiotics, Antitubercular
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 065421

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RIFAMPIN	rifampin	INJECTABLE;INJECTION	065421	ANDA	Mylan Institutional LLC	67457-445	67457-445-60	1 VIAL in 1 CARTON (67457-445-60) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	600MG/VIAL
Approval Date:	May 22, 2008	TE:	AP	RLD:	No

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