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Generated: April 22, 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 two NDAs. It is available from two 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 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 Action	Calcineurin Inhibitors

Medical Subject Heading (MeSH) Categories for 050709

Calcineurin Inhibitors
Immunosuppressive Agents

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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/ML
Approval Date:	Apr 8, 1994	TE:	AP	RLD:	Yes

Expired US Patents for NDA 050709

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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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