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Generated: May 25, 2019

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Details for New Drug Application (NDA): 209566

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NDA 209566 describes SEIZALAM, which is a drug marketed by Meridian Medcl Techn and is included in one NDA. It is available from one supplier. Additional details are available on the SEIZALAM profile page.

The generic ingredient in SEIZALAM is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.
Summary for 209566
Tradename:SEIZALAM
Applicant:Meridian Medcl Techn
Ingredient:midazolam hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209566
Suppliers and Packaging for NDA: 209566
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SEIZALAM midazolam hydrochloride SOLUTION;INTRAMUSCULAR 209566 NDA Meridian Medical Technologies, Inc. 11704-650 11704-650-10 10 VIAL, GLASS in 1 CARTON (11704-650-10) > 10 mL in 1 VIAL, GLASS (11704-650-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULARStrengthEQ 50MG BASE/10ML (EQ 5MG BASE/ML)
Approval Date:Sep 14, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 14, 2025
Regulatory Exclusivity Use:TREATMENT OF STATUS EPILEPTICUS IN ADULTS

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