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Serving leading biopharmaceutical companies globally:

US Department of Justice
Queensland Health
US Army
Daiichi Sankyo
Argus Health

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065003

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NDA 065003 describes GENGRAF, which is a drug marketed by Abbvie and is included in one NDA. It is available from two suppliers. Additional details are available on the GENGRAF profile page.

The generic ingredient in GENGRAF is cyclosporine. There are seventeen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
Summary for 065003
Therapeutic Class:Immunological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 065003
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GENGRAF cyclosporine CAPSULE;ORAL 065003 ANDA AbbVie Inc. 0074-0541 N 0074-0541-30
GENGRAF cyclosporine CAPSULE;ORAL 065003 ANDA AbbVie Inc. 0074-3108 N 0074-3108-32

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:May 12, 2000TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:May 12, 2000TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:May 12, 2000TE:AB1RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Boehringer Ingelheim

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