BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Argus Health
Cerilliant
Dow
Teva
Novartis
Express Scripts
AstraZeneca
UBS
Fuji
Farmers Insurance

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091195

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NDA 091195 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 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 091195
Tradename:TACROLIMUS
Applicant:Accord Hlthcare
Ingredient:tacrolimus
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091195
Mechanism of ActionCalcineurin Inhibitors
Medical Subject Heading (MeSH) Categories for 091195
Suppliers and Packaging for NDA: 091195
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TACROLIMUS tacrolimus CAPSULE;ORAL 091195 ANDA Major Pharmaceuticals 0904-6425 0904-6425-61 100 BLISTER PACK in 1 CARTON (0904-6425-61) > 1 CAPSULE in 1 BLISTER PACK
TACROLIMUS tacrolimus CAPSULE;ORAL 091195 ANDA Accord Healthcare Inc. 16729-041 16729-041-01 100 CAPSULE in 1 BOTTLE (16729-041-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.5MG BASE
Approval Date:Aug 31, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Aug 31, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Aug 31, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Colorcon
Daiichi Sankyo
Boehringer Ingelheim
Harvard Business School
Mallinckrodt
McKinsey
Cerilliant
Deloitte
Farmers Insurance

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