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Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078066

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NDA 078066 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 078066
Tradename:CALCITRIOL
Applicant:Akorn
Ingredient:calcitriol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078066
Ingredient-typeCholecalciferol
Medical Subject Heading (MeSH) Categories for 078066
Suppliers and Packaging for NDA: 078066
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCITRIOL calcitriol INJECTABLE;INJECTION 078066 ANDA Akorn, Inc. 17478-831 N 17478-831-01
CALCITRIOL calcitriol INJECTABLE;INJECTION 078066 ANDA Akorn, Inc. 17478-931 N 17478-931-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.001MG/ML
Approval Date:Jan 29, 2008TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.002MG/ML
Approval Date:Jan 29, 2008TE:RLD:No

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