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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. It is available from one supplier. 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. Twenty-one suppliers are listed for this compound. Additional details are available on the calcitriol profile page.

Summary for NDA: 018874

Tradename:
CALCIJEX
Applicant:
Abbvie
Ingredient:
calcitriol
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 018874

Ingredient-typeCholecalciferol

Suppliers and Packaging for NDA: 018874

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCIJEX
calcitriol
INJECTABLE;INJECTION 018874 NDA AbbVie Inc. 0074-8110 0074-8110-31 5 AMPULE in 1 CARTON (0074-8110-31) > 1 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.001MG/ML
Approval Date:Sep 25, 1986TE:RLD:No
Patent:6,051,567*PEDPatent Expiration:Feb 2, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:6,265,392*PEDPatent Expiration:Feb 2, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:6,274,169*PEDPatent Expiration:Feb 2, 2020Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 018874

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
CALCIJEX
calcitriol
INJECTABLE;INJECTION018874-002Sep 25, 19863,697,559► subscribe
Abbvie
CALCIJEX
calcitriol
INJECTABLE;INJECTION018874-002Sep 25, 19864,308,264*PED► subscribe
Abbvie
CALCIJEX
calcitriol
INJECTABLE;INJECTION018874-001Sep 25, 19863,697,559► subscribe
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