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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
US Department of Justice
Harvard Business School
Federal Trade Commission
Deloitte
Healthtrust
Fish and Richardson
Queensland Health
QuintilesIMS

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091412

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NDA 091412 describes PARICALCITOL, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Bionpharma Inc, Dr Reddys Labs Ltd, Eci Pharms Llc, Marksans Pharma, Rising Pharms Inc, Teva Pharms Usa, Accord Hlthcare, Akorn, Amneal Pharms Co, Hikma Pharms, Hospira Inc, Mylan Labs Ltd, and Sandoz Inc, and is included in sixteen NDAs. It is available from fifteen suppliers. Additional details are available on the PARICALCITOL profile page.

The generic ingredient in PARICALCITOL is paricalcitol. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.
Summary for 091412
Tradename:PARICALCITOL
Applicant:Dr Reddys Labs Ltd
Ingredient:paricalcitol
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091412
Ingredient-typeCholecalciferol
Suppliers and Packaging for NDA: 091412
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PARICALCITOL paricalcitol CAPSULE;ORAL 091412 ANDA Dr. Reddy's Laboratories Limited 55111-663 N 55111-663-05
PARICALCITOL paricalcitol CAPSULE;ORAL 091412 ANDA Dr. Reddy's Laboratories Limited 55111-663 N 55111-663-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1MCG
Approval Date:Jun 24, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2MCG
Approval Date:Jun 24, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength4MCG
Approval Date:Jun 24, 2014TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
McKinsey
Queensland Health
Daiichi Sankyo
Medtronic
Chubb
QuintilesIMS
Cipla
Deloitte

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