Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 206223

Expand all

REMIFENTANIL HYDROCHLORIDE (REMIFENTANIL HYDROCHLORIDE)
EQ 1MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: REMIFENTANIL HYDROCHLORIDE
Proprietary Name: REMIFENTANIL HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A206223
Product Number: 001
Approval Date: Jan 16, 2018
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

REMIFENTANIL HYDROCHLORIDE (REMIFENTANIL HYDROCHLORIDE)
EQ 2MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: REMIFENTANIL HYDROCHLORIDE
Proprietary Name: REMIFENTANIL HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A206223
Product Number: 002
Approval Date: Jan 16, 2018
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

REMIFENTANIL HYDROCHLORIDE (REMIFENTANIL HYDROCHLORIDE)
EQ 5MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: REMIFENTANIL HYDROCHLORIDE
Proprietary Name: REMIFENTANIL HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 5MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A206223
Product Number: 003
Approval Date: Jan 16, 2018
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information