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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 065502

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NDA 065502 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 thirteen 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 065502

Tradename:	RIFAMPIN
Applicant:	Epic Pharma Llc
Ingredient:	rifampin
Patents:	0

Medical Subject Heading (MeSH) Categories for 065502

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	600MG/VIAL
Approval Date:	Sep 21, 2010	TE:	AP	RLD:	No

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