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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 two 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 NDA: 090033

Tradename:
RIFABUTIN
Applicant:
Lupin Ltd
Ingredient:
rifabutin
Patents:0
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 090033

Ingredient-typeRifamycins

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 60687-198-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-198-25) > 1 CAPSULE in 1 BLISTER PACK (60687-198-95)
RIFABUTIN
rifabutin
CAPSULE;ORAL 090033 ANDA Lupin Pharmaceuticals, Inc. 68180-285 68180-285-01 100 CAPSULE in 1 BOTTLE (68180-285-01)

Summary for product number 001

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


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