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Serving leading biopharmaceutical companies globally:

Argus Health
Colorcon
Chubb
Express Scripts
Mallinckrodt
Citi
US Department of Justice
UBS
Fish and Richardson
McKesson

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075746

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NDA 075746 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 075746
Tradename:CALCITRIOL
Applicant:Luitpold
Ingredient:calcitriol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075746
Ingredient-typeCholecalciferol
Medical Subject Heading (MeSH) Categories for 075746
Suppliers and Packaging for NDA: 075746
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCITRIOL calcitriol INJECTABLE;INJECTION 075746 ANDA Physicians Total Care, Inc. 54868-6265 E 54868-6265-0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.001MG/ML
Approval Date:Sep 26, 2003TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.002MG/ML
Approval Date:Sep 26, 2003TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Fuji
QuintilesIMS
Citi
Harvard Business School
Teva
Accenture
AstraZeneca
Julphar

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