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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 216359


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NDA 216359 describes MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR), which is a drug marketed by Rafa Labs Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) profile page.

The generic ingredient in MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.
Summary for 216359
Pharmacology for NDA: 216359
Suppliers and Packaging for NDA: 216359
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) midazolam hydrochloride SOLUTION;INTRAMUSCULAR 216359 NDA Rafa Laboratories, Ltd. 71053-595 71053-595-01 480 CARTON in 1 BOX (71053-595-01) / 40 SYRINGE in 1 CARTON / .7 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAMUSCULARStrengthEQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)
Approval Date:Aug 8, 2022TE:RLD:Yes

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