U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 214074

Expand all

ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE HYDROCHLORIDE)
40MG/20ML (2MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: ROPIVACAINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 40MG/20ML (2MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A214074
Product Number: 001
Approval Date: Jul 20, 2020
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE HYDROCHLORIDE)
150MG/20ML (7.5MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: ROPIVACAINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 150MG/20ML (7.5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A214074
Product Number: 003
Approval Date: Jul 20, 2020
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE HYDROCHLORIDE)
150MG/30ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: ROPIVACAINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 150MG/30ML (5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A214074
Product Number: 002
Approval Date: Jul 20, 2020
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE HYDROCHLORIDE)
200MG/20ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: ROPIVACAINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 200MG/20ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A214074
Product Number: 004
Approval Date: Jul 20, 2020
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top