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Serving leading biopharmaceutical companies globally:

Novartis
Moodys
Colorcon
Covington
Boehringer Ingelheim
Harvard Business School
Cerilliant
Accenture
Farmers Insurance
Argus Health

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090509

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NDA 090509 describes TACROLIMUS, which is a drug marketed by Hospira Inc, Panacea Biotec Ltd, Watson Labs, Dr Reddys Labs Ltd, Fougera Pharms Inc, Sandoz, Strides Pharma, Accord Hlthcare, and Mylan, 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-eight suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.

Summary for NDA: 090509

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090509

Mechanism of ActionCalcineurin Inhibitors

Suppliers and Packaging for NDA: 090509

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TACROLIMUS
tacrolimus
CAPSULE;ORAL 090509 ANDA Major Pharmaceuticals 0904-6623 0904-6623-61 100 BLISTER PACK in 1 CARTON (0904-6623-61) > 1 CAPSULE in 1 BLISTER PACK
TACROLIMUS
tacrolimus
CAPSULE;ORAL 090509 ANDA Major Pharmaceuticals 0904-6624 0904-6624-61 100 BLISTER PACK in 1 CARTON (0904-6624-61) > 1 CAPSULE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.5MG BASE
Approval Date:May 12, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:May 12, 2010TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:May 12, 2010TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Moodys
McKesson
US Army
Healthtrust
Teva
US Department of Justice
Accenture
Argus Health
Fish and Richardson
UBS

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