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 NDA 215868

Expand all

MIDAZOLAM IN 0.8% SODIUM CHLORIDE (MIDAZOLAM)
50MG/50ML (1MG/ML)
Marketing Status: Prescription
Active Ingredient: MIDAZOLAM
Proprietary Name: MIDAZOLAM IN 0.8% SODIUM CHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 50MG/50ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215868
Product Number: 001
Approval Date: Jul 20, 2022
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
MIDAZOLAM IN 0.8% SODIUM CHLORIDE (MIDAZOLAM)
100MG/100ML (1MG/ML)
Marketing Status: Prescription
Active Ingredient: MIDAZOLAM
Proprietary Name: MIDAZOLAM IN 0.8% SODIUM CHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MG/100ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215868
Product Number: 002
Approval Date: Jul 20, 2022
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top