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Details for New Drug Application (NDA): 061884

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NDA 061884 describes RIFAMATE, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. Additional details are available on the RIFAMATE profile page.

The generic ingredient in RIFAMATE 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: 061884

Tradename:
RIFAMATE
Applicant:
Sanofi Aventis Us
Ingredient:
isoniazid; rifampin
Patents:0
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 061884

Ingredient-typeRifamycins

Suppliers and Packaging for NDA: 061884

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIFAMATE
isoniazid; rifampin
CAPSULE;ORAL 061884 ANDA sanofi-aventis U.S. LLC 0068-0509 0068-0509-60 60 CAPSULE in 1 BOTTLE (0068-0509-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG;300MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes


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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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