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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Federal Trade Commission
Cerilliant
Colorcon
Mallinckrodt
US Department of Justice
Fuji
McKinsey
Queensland Health
Cipla

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091174

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NDA 091174 describes CALCITRIOL, which is a drug marketed by Amneal Pharms, Bionpharma Inc, Strides Pharma, Teva, West-ward Pharms Int, Akorn, Fresenius Kabi Usa, Fresenius Medcl, Hospira, Luitpold, Rockwell Medcl, Sagent Pharms, and Teva Parenteral, and is included in fourteen NDAs. It is available from fourteen suppliers. Additional details are available on the CALCITRIOL profile page.

The generic ingredient in CALCITRIOL is calcitriol. There are ten drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the calcitriol profile page.
Summary for 091174
Tradename:CALCITRIOL
Applicant:Bionpharma Inc
Ingredient:calcitriol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091174
Ingredient-typeCholecalciferol
Medical Subject Heading (MeSH) Categories for 091174
Suppliers and Packaging for NDA: 091174
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCITRIOL calcitriol CAPSULE;ORAL 091174 ANDA KAISER FOUNDATION HOSPITALS 0179-0196 0179-0196-70 30 CAPSULE, LIQUID FILLED in 1 BOX, UNIT-DOSE (0179-0196-70)
CALCITRIOL calcitriol CAPSULE;ORAL 091174 ANDA KAISER FOUNDATION HOSPITALS 0179-0197 0179-0197-70 30 CAPSULE, LIQUID FILLED in 1 BOX, UNIT-DOSE (0179-0197-70)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.25MCG
Approval Date:May 24, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MCG
Approval Date:May 24, 2013TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Deloitte
Argus Health
US Army
Fish and Richardson
Farmers Insurance
Medtronic
QuintilesIMS
Harvard Business School
Boehringer Ingelheim

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