Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208266

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DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE HYDROCHLORIDE)
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Marketing Status: Prescription

Active Ingredient: DEXMEDETOMIDINE HYDROCHLORIDE
Proprietary Name: DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A208266
Product Number: 001
Approval Date: Sep 15, 2020
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE HYDROCHLORIDE)
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Marketing Status: Prescription

Active Ingredient: DEXMEDETOMIDINE HYDROCHLORIDE
Proprietary Name: DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A208266
Product Number: 002
Approval Date: Sep 15, 2020
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information