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Serving hundreds of leading biopharmaceutical companies globally:

Citi
UBS
Harvard Business School
Daiichi Sankyo
Mallinckrodt
Fuji
Merck
Fish and Richardson
Teva

Generated: July 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065461

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NDA 065461 describes TACROLIMUS, which is a drug marketed by Accord Hlthcare, Belcher Pharms Llc, Dr Reddys Labs Ltd, Mylan, Panacea Biotec Ltd, Sandoz, Strides Pharma, Watson Labs, Hospira Inc, Fougera Pharms Inc, and Glenmark Pharms Ltd, and is included in eleven NDAs. It is available from twenty suppliers. Additional details are available on the TACROLIMUS profile page.

The generic ingredient in TACROLIMUS 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 065461
Tradename:TACROLIMUS
Applicant:Sandoz
Ingredient:tacrolimus
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 065461
Mechanism of ActionCalcineurin Inhibitors
Medical Subject Heading (MeSH) Categories for 065461
Suppliers and Packaging for NDA: 065461
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TACROLIMUS tacrolimus CAPSULE;ORAL 065461 ANDA KAISER FOUNDATION HOSPITALS 0179-0079 N 0179-0079-70
TACROLIMUS tacrolimus CAPSULE;ORAL 065461 ANDA Sandoz Inc 0781-2102 N 0781-2102-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.5MG BASE
Approval Date:Aug 10, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Aug 10, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Aug 10, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Covington
McKinsey
Boehringer Ingelheim
Chinese Patent Office
Dow
Citi
QuintilesIMS
Accenture

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