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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021038

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PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE)
EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)
Marketing Status: Prescription
Active Ingredient: DEXMEDETOMIDINE HYDROCHLORIDE
Proprietary Name: PRECEDEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021038
Product Number: 005
Approval Date: Jan 31, 2020
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE)
EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)
Marketing Status: Prescription
Active Ingredient: DEXMEDETOMIDINE HYDROCHLORIDE
Proprietary Name: PRECEDEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021038
Product Number: 004
Approval Date: Nov 14, 2014
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE)
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Marketing Status: Prescription
Active Ingredient: DEXMEDETOMIDINE HYDROCHLORIDE
Proprietary Name: PRECEDEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021038
Product Number: 001
Approval Date: Dec 17, 1999
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE)
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Marketing Status: Prescription
Active Ingredient: DEXMEDETOMIDINE HYDROCHLORIDE
Proprietary Name: PRECEDEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021038
Product Number: 002
Approval Date: Mar 13, 2013
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE)
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Marketing Status: Prescription
Active Ingredient: DEXMEDETOMIDINE HYDROCHLORIDE
Proprietary Name: PRECEDEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021038
Product Number: 003
Approval Date: Mar 13, 2013
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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