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Generated: June 24, 2017

DrugPatentWatch Database Preview

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 two 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-six suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.

Summary for NDA: 050708

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 050708

Mechanism of ActionCalcineurin Inhibitors

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

Summary for product number 001

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

Summary for product number 002

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

Summary 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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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Citi
Moodys
Fuji
Julphar
Covington
Medtronic
Deloitte
McKesson
Chinese Patent Office

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.

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