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Serving leading biopharmaceutical companies globally:

Chubb
Argus Health
Teva
Harvard Business School
US Army
McKesson
Accenture
Healthtrust
Cerilliant
Colorcon

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204948

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NDA 204948 describes PARICALCITOL, which is a drug marketed by Sandoz Inc, Eci Pharms Llc, Dr Reddys Labs Ltd, Hikma Pharms, Rising Pharms Inc, Amneal Pharms, Teva Pharms Usa, Bionpharma Inc, Marksans Pharma, Hospira Inc, Aurobindo Pharma Ltd, Accord Hlthcare, and Amneal Pharms Co, and is included in fourteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.

Summary for NDA: 204948

Tradename:
1
Applicant:
1
Ingredient:
1
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 25000-012-03 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-012-03)
PARICALCITOL
paricalcitol
CAPSULE;ORAL 204948 ANDA MARKSANS PHARMA LIMITED 25000-012 25000-012-50 4 BAG in 1 BOX (25000-012-50) > 10000 CAPSULE, LIQUID FILLED in 1 BAG

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
McKesson
Cantor Fitzgerald
Queensland Health
Fuji
US Department of Justice
Daiichi Sankyo
Covington
Novartis

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