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Last Updated: September 25, 2022

Details for New Drug Application (NDA): 021038


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NDA 021038 describes PRECEDEX, which is a drug marketed by Hospira and is included in one NDA. It is available from three suppliers. There are seven patents protecting this drug and three Paragraph IV challenges. Additional details are available on the PRECEDEX profile page.

The generic ingredient in PRECEDEX is dexmedetomidine hydrochloride. There are fourteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
Summary for 021038
Tradename:PRECEDEX
Applicant:Hospira
Ingredient:dexmedetomidine hydrochloride
Patents:7
Formulation / Manufacturing:see details
Pharmacology for NDA: 021038
Mechanism of ActionAdrenergic alpha2-Agonists
Physiological Effect General Anesthesia
Medical Subject Heading (MeSH) Categories for 021038
Suppliers and Packaging for NDA: 021038
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038 NDA Henry Schein, Inc. 0404-9938 0404-9938-02 1 VIAL in 1 BAG (0404-9938-02) > 2 mL in 1 VIAL
PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038 NDA Hospira, Inc. 0409-1174 0409-1174-10 10 BOTTLE in 1 TRAY (0409-1174-10) > 100 mL in 1 BOTTLE (0409-1174-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date:Dec 17, 1999TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date:Mar 13, 2013TE:APRLD:Yes
Patent:See Plans and PricingPatent Expiration:Jan 4, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Jul 4, 2032Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021038

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