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Baxter
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US Department of Justice
Express Scripts
Mallinckrodt
Farmers Insurance
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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090687

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NDA 090687 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 fifteen 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 suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
Summary for 090687
Tradename:TACROLIMUS
Applicant:Strides Pharma
Ingredient:tacrolimus
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090687
Mechanism of ActionCalcineurin Inhibitors
Medical Subject Heading (MeSH) Categories for 090687
Suppliers and Packaging for NDA: 090687
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TACROLIMUS tacrolimus CAPSULE;ORAL 090687 ANDA Strides Shasun Limited 64380-720 N 64380-720-06
TACROLIMUS tacrolimus CAPSULE;ORAL 090687 ANDA Strides Shasun Limited 64380-720 N 64380-720-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.5MG BASE
Approval Date:Jul 22, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Jul 22, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Jul 22, 2014TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Cerilliant
Merck
US Army
Fuji
Baxter
QuintilesIMS
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