Product Details for ANDA 212791
DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE HYDROCHLORIDE)
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Marketing Status: Prescription
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Marketing Status: Prescription
EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)
Marketing Status: Discontinued
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: A212791
Product Number: 001
Approval Date: Dec 4, 2019
Applicant Holder Full Name: SLAYBACK PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
DEXMEDETOMIDINE HYDROCHLORIDE (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: A212791
Product Number: 001
Approval Date: Dec 4, 2019
Applicant Holder Full Name: SLAYBACK PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A212791
Product Number: 002
Approval Date: Dec 4, 2019
Applicant Holder Full Name: SLAYBACK PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
DEXMEDETOMIDINE HYDROCHLORIDE (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: A212791
Product Number: 002
Approval Date: Dec 4, 2019
Applicant Holder Full Name: SLAYBACK PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)
Marketing Status: Discontinued
Active Ingredient: DEXMEDETOMIDINE HYDROCHLORIDE
Proprietary Name: DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A212791
Product Number: 003
Approval Date: May 8, 2020
Applicant Holder Full Name: SLAYBACK PHARMA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A212791
Product Number: 003
Approval Date: May 8, 2020
Applicant Holder Full Name: SLAYBACK PHARMA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information