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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211844

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MIDAZOLAM IN 0.9% SODIUM CHLORIDE (MIDAZOLAM)
50MG/50ML (1MG/ML)
Marketing Status: Prescription
Active Ingredient: MIDAZOLAM
Proprietary Name: MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 50MG/50ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N211844
Product Number: 001
Approval Date: Mar 22, 2021
Applicant Holder Full Name: INFORLIFE SA
Marketing Status:  Prescription
Patent and Exclusivity Information
MIDAZOLAM IN 0.9% SODIUM CHLORIDE (MIDAZOLAM)
100MG/100ML (1MG/ML)
Marketing Status: Prescription
Active Ingredient: MIDAZOLAM
Proprietary Name: MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MG/100ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N211844
Product Number: 002
Approval Date: Mar 22, 2021
Applicant Holder Full Name: INFORLIFE SA
Marketing Status:  Prescription
Patent and Exclusivity Information
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