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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090033

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NDA 090033 describes RIFABUTIN, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from three suppliers. Additional details are available on the RIFABUTIN profile page.

The generic ingredient in RIFABUTIN is rifabutin. There are three drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the rifabutin profile page.
Summary for 090033
Tradename:RIFABUTIN
Applicant:Lupin Ltd
Ingredient:rifabutin
Patents:0
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 090033
Ingredient-typeRifamycins
Medical Subject Heading (MeSH) Categories for 090033
Suppliers and Packaging for NDA: 090033
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIFABUTIN rifabutin CAPSULE;ORAL 090033 ANDA American Health Packaging 60687-198 N 60687-198-25
RIFABUTIN rifabutin CAPSULE;ORAL 090033 ANDA Lupin Pharmaceuticals, Inc. 68180-285 N 68180-285-07

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Feb 24, 2014TE:ABRLD:No

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