U.S. flag An official website of the United States government
  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 212847

Expand all

MIDAZOLAM HYDROCHLORIDE (MIDAZOLAM HYDROCHLORIDE)
EQ 1MG BASE/ML
Marketing Status: Prescription
Active Ingredient: MIDAZOLAM HYDROCHLORIDE
Proprietary Name: MIDAZOLAM HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212847
Product Number: 001
Approval Date: Dec 11, 2020
Applicant Holder Full Name: HIKMA PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
MIDAZOLAM HYDROCHLORIDE (MIDAZOLAM HYDROCHLORIDE)
EQ 5MG BASE/ML
Marketing Status: Prescription
Active Ingredient: MIDAZOLAM HYDROCHLORIDE
Proprietary Name: MIDAZOLAM HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 5MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212847
Product Number: 002
Approval Date: Dec 11, 2020
Applicant Holder Full Name: HIKMA PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top