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Generated: November 13, 2018

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Details for New Drug Application (NDA): 050709

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NDA 050709 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 050709
Tradename:PROGRAF
Applicant:Astellas
Ingredient:tacrolimus
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050709
Mechanism of ActionCalcineurin Inhibitors
Medical Subject Heading (MeSH) Categories for 050709
Suppliers and Packaging for NDA: 050709
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROGRAF tacrolimus INJECTABLE;INJECTION 050709 NDA Astellas Pharma US, Inc. 0469-3016 0469-3016-01 10 AMPULE in 1 BOX (0469-3016-01) > 1 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Apr 8, 1994TE:APRLD:Yes

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