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Generated: December 18, 2018

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Details for New Drug Application (NDA): 050689

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NDA 050689 describes MYCOBUTIN, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from three suppliers. Additional details are available on the MYCOBUTIN profile page.

The generic ingredient in MYCOBUTIN is rifabutin. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the rifabutin profile page.
Summary for 050689
Tradename:MYCOBUTIN
Applicant:Pharmacia And Upjohn
Ingredient:rifabutin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050689
Medical Subject Heading (MeSH) Categories for 050689
Suppliers and Packaging for NDA: 050689
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYCOBUTIN rifabutin CAPSULE;ORAL 050689 NDA Pharmacia and Upjohn Company LLC 0013-5301 0013-5301-17 100 CAPSULE in 1 BOTTLE (0013-5301-17)
MYCOBUTIN rifabutin CAPSULE;ORAL 050689 NDA Department of State Health Services, Pharmacy Branch 55695-010 55695-010-00 100 CAPSULE in 1 BOTTLE (55695-010-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Dec 23, 1992TE:ABRLD:Yes

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