Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050709

« Back to Dashboard

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 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial
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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.