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Generated: May 25, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016324

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NDA 016324 describes IMURAN, which is a drug marketed by Casper Pharma Llc and Sebela Ireland Ltd and is included in two NDAs. It is available from two suppliers. Additional details are available on the IMURAN profile page.

The generic ingredient in IMURAN is azathioprine. There are sixteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the azathioprine profile page.
Summary for 016324
Applicant:Sebela Ireland Ltd
Formulation / Manufacturing:see details
Pharmacology for NDA: 016324
Suppliers and Packaging for NDA: 016324
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMURAN azathioprine TABLET;ORAL 016324 NDA Sebela Pharmaceuticals Inc. 54766-590 54766-590-10 100 TABLET in 1 BOTTLE (54766-590-10)
IMURAN azathioprine TABLET;ORAL 016324 NDA Prometheus Laboratories Inc. 65483-590 65483-590-10 100 TABLET in 1 BOTTLE (65483-590-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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