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Generated: July 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016324

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

The generic ingredient in IMURAN is azathioprine sodium. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the azathioprine sodium profile page.

Summary for NDA: 016324

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Immunological Agents
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 Prometheus Laboratories Inc. 65483-590 65483-590-10 100 TABLET in 1 BOTTLE (65483-590-10)

Summary for product number 001

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

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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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Serving 500+ biopharmaceutical companies globally:

Covington
Medtronic
Johnson and Johnson
Moodys
Chubb
Healthtrust
AstraZeneca
US Army
Express Scripts
Mallinckrodt

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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