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Serving leading biopharmaceutical companies globally:

Novartis
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Accenture
Merck
Healthtrust
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Federal Trade Commission
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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075568

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NDA 075568 describes AZATHIOPRINE, which is a drug marketed by Amneal Pharms Llc, Mylan, Zydus Pharms Usa, and West-ward Pharms Int, and is included in four NDAs. It is available from fourteen suppliers. Additional details are available on the AZATHIOPRINE profile page.

The generic ingredient in AZATHIOPRINE 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 075568
Tradename:AZATHIOPRINE
Applicant:Mylan
Ingredient:azathioprine
Patents:0
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075568
Suppliers and Packaging for NDA: 075568
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZATHIOPRINE azathioprine TABLET;ORAL 075568 ANDA Mylan Pharmaceuticals Inc. 0378-1005 0378-1005-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-1005-01)
AZATHIOPRINE azathioprine TABLET;ORAL 075568 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-745 43353-745-09 9000 TABLET in 1 BOTTLE, PLASTIC (43353-745-09)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Dec 13, 1999TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Farmers Insurance
Daiichi Sankyo
UBS
Baxter
Harvard Business School
Mallinckrodt
Merck
Julphar

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