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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
QuintilesIMS
Daiichi Sankyo
US Department of Justice
Boehringer Ingelheim
Colorcon
Cerilliant
US Army
Chubb

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204948

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NDA 204948 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 204948
Tradename:PARICALCITOL
Applicant:Marksans Pharma
Ingredient:paricalcitol
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204948
Ingredient-typeCholecalciferol
Suppliers and Packaging for NDA: 204948
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PARICALCITOL paricalcitol CAPSULE;ORAL 204948 ANDA MARKSANS PHARMA LIMITED 25000-012 N 25000-012-03
PARICALCITOL paricalcitol CAPSULE;ORAL 204948 ANDA MARKSANS PHARMA LIMITED 25000-012 N 25000-012-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1MCG
Approval Date:Oct 7, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2MCG
Approval Date:Oct 7, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength4MCG
Approval Date:Oct 7, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Chubb
Farmers Insurance
UBS
QuintilesIMS
Fuji
Argus Health
Moodys
Julphar

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