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Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065421

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NDA 065421 describes RIFAMPIN, which is a drug marketed by Akorn, Lannett, 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-five 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 065421
Tradename:RIFAMPIN
Applicant:Mylan Labs Ltd
Ingredient:rifampin
Patents:0
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details
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 Pfizer Laboratories Div Pfizer Inc 0069-0112 E 0069-0112-01
RIFAMPIN rifampin INJECTABLE;INJECTION 065421 ANDA Pfizer Laboratories Div Pfizer Inc 0069-0141 E 0069-0141-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength600MG/VIAL
Approval Date:May 22, 2008TE:APRLD:No

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