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Teva
Farmers Insurance
US Army
Daiichi Sankyo
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McKesson
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Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090596

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NDA 090596 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, and Fougera Pharms Inc, and is included in ten NDAs. It is available from seventeen 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-four suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
Summary for 090596
Tradename:TACROLIMUS
Applicant:Mylan
Ingredient:tacrolimus
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090596
Mechanism of ActionCalcineurin Inhibitors
Medical Subject Heading (MeSH) Categories for 090596
Suppliers and Packaging for NDA: 090596
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TACROLIMUS tacrolimus CAPSULE;ORAL 090596 ANDA Mylan Pharmaceuticals Inc. 0378-2045 N 0378-2045-01
TACROLIMUS tacrolimus CAPSULE;ORAL 090596 ANDA Mylan Pharmaceuticals Inc. 0378-2046 N 0378-2046-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.5MG BASE
Approval Date:Sep 17, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Sep 17, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Sep 17, 2010TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Deloitte
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Federal Trade Commission
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Citi
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Julphar
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