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Last Updated: October 26, 2020

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Details for New Drug Application (NDA): 018874

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NDA 018874 describes CALCIJEX, which is a drug marketed by Abbvie and is included in one NDA. There are three patents protecting this drug. Additional details are available on the CALCIJEX profile page.

The generic ingredient in CALCIJEX is calcitriol. There are ten drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the calcitriol profile page.
Summary for 018874
Tradename:CALCIJEX
Applicant:Abbvie
Ingredient:calcitriol
Patents:3
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 018874
Paragraph IV (Patent) Challenges for 018874
Tradename Dosage Ingredient NDA Submissiondate
CALCIJEX INJECTABLE;INJECTION calcitriol 018874

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Sep 25, 1986TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 2, 2020Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Feb 2, 2020Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Feb 2, 2020Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 018874

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie CALCIJEX calcitriol INJECTABLE;INJECTION 018874-001 Sep 25, 1986   Start Trial   Start Trial
Abbvie CALCIJEX calcitriol INJECTABLE;INJECTION 018874-001 Sep 25, 1986   Start Trial   Start Trial
Abbvie CALCIJEX calcitriol INJECTABLE;INJECTION 018874-002 Sep 25, 1986   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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