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Generated: November 15, 2018

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Details for New Drug Application (NDA): 050708

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NDA 050708 describes PROGRAF, which is a drug marketed by Astellas and is included in three NDAs. It is available from three suppliers. Additional details are available on the PROGRAF profile page.

The generic ingredient in PROGRAF is tacrolimus. There are twenty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
Summary for 050708
Tradename:PROGRAF
Applicant:Astellas
Ingredient:tacrolimus
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050708
Mechanism of ActionCalcineurin Inhibitors
Medical Subject Heading (MeSH) Categories for 050708
Suppliers and Packaging for NDA: 050708
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROGRAF tacrolimus CAPSULE;ORAL 050708 NDA Astellas Pharma US, Inc. 0469-0607 0469-0607-73 1 BOTTLE in 1 CARTON (0469-0607-73) > 100 CAPSULE, GELATIN COATED in 1 BOTTLE
PROGRAF tacrolimus CAPSULE;ORAL 050708 NDA Astellas Pharma US, Inc. 0469-0617 0469-0617-11 10 BLISTER PACK in 1 CARTON (0469-0617-11) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Apr 8, 1994TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Apr 8, 1994TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.5MG BASE
Approval Date:Aug 24, 1998TE:ABRLD:Yes

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