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Generated: May 28, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204101

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NDA 204101 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 204101
Tradename:RIFAMPIN
Applicant:Emcure Pharms Ltd
Ingredient:rifampin
Patents:0
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204101
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIFAMPIN rifampin INJECTABLE;INJECTION 204101 ANDA Heritage Pharmaceuticals Inc. 23155-340 N 23155-340-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength600MG/VIAL
Approval Date:Aug 18, 2014TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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