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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
UBS
Colorcon
US Army
Fish and Richardson
Moodys
Healthtrust
Federal Trade Commission
Chubb

Generated: June 25, 2018

DrugPatentWatch Database Preview

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 four 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-seven 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
Therapeutic Class:Dermatological Agents
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 N 0469-3016-01

Profile for product number 001

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

Expired US Patents for NDA 050709

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas PROGRAF tacrolimus INJECTABLE;INJECTION 050709-001 Apr 8, 1994 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Dow
Johnson and Johnson
Cipla
Express Scripts
Moodys
Argus Health
Teva
Chubb

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