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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
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US Army
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Generated: December 18, 2017

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, Dr Reddys Labs Ltd, Mylan, Panacea Biotec Ltd, Sandoz, Strides Pharma, Watson Labs, Hospira Inc, and Fougera Pharms Inc, and is included in nine 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:1
Applicant:1
Ingredient:1
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 Novartis Pharmaceuticals Corporation 0078-0616 0078-0616-05 100 CAPSULE in 1 BOTTLE (0078-0616-05)
TACROLIMUS tacrolimus CAPSULE;ORAL 065461 ANDA Novartis Pharmaceuticals Corporation 0078-0617 0078-0617-05 100 CAPSULE in 1 BOTTLE (0078-0617-05)

Summary for product number 001

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

Summary for product number 002

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

Summary 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 leading biopharmaceutical companies globally:

Cipla
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Dow
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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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