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Details for New Drug Application (NDA): 204101

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NDA 204101 describes RIFAMPIN, which is a drug marketed by Emcure Pharms Ltd, Akorn, West-ward Pharms Int, Mylan Labs Ltd, Lupin Pharms, Watson Pharms Teva, Hikma Pharms, Sandoz, Fresenius Kabi Usa, Lannett, and Hikma Intl Pharms, and is included in twelve NDAs. It is available from twenty-six 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 NDA: 204101

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 204101

Ingredient-typeRifamycins

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 23155-340-31 10 mL in 1 VIAL, GLASS (23155-340-31)

Summary for product number 001

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


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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