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Generated: December 10, 2018

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Details for New Drug Application (NDA): 065502

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NDA 065502 describes RIFAMPIN, which is a drug marketed by Akorn, Lannett Co Inc, Lupin Pharms, Sandoz, Emcure Pharms Ltd, Fresenius Kabi Usa, Hikma Pharms, Mylan Labs Ltd, Watson Pharms Teva, West-ward Pharms Int, and Hikma Intl Pharms, and is included in twelve NDAs. It is available from twenty-four 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. Two suppliers are listed for this compound. Additional details are available on the isoniazid; rifampin profile page.
Summary for 065502
Tradename:RIFAMPIN
Applicant:Akorn
Ingredient:rifampin
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 065502
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIFAMPIN rifampin INJECTABLE;INJECTION 065502 ANDA AKORN, Inc. 17478-151 17478-151-42 1 VIAL in 1 BOX, UNIT-DOSE (17478-151-42) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength600MG/VIAL
Approval Date:Sep 21, 2010TE:APRLD:No

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