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Generated: November 17, 2018

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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 eighteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
Summary for 065003
Tradename:GENGRAF
Applicant:Abbvie
Ingredient:cyclosporine
Patents:0
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. 0074-3108 0074-3108-32 3 BLISTER PACK in 1 CARTON (0074-3108-32) > 10 CAPSULE in 1 BLISTER PACK
GENGRAF cyclosporine CAPSULE;ORAL 065003 ANDA AbbVie Inc. 0074-3109 0074-3109-32 5 BLISTER PACK in 1 CARTON (0074-3109-32) > 6 CAPSULE in 1 BLISTER PACK

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:DISCNDosage:CAPSULE;ORALStrength50MG
Approval Date:May 12, 2000TE:RLD:No

Profile for product number 003

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

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