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FDA Approval

Seizalam

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
January 26, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Midazolam(5 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Hospira, Inc.

Meridian Medical Technologies LLC

827731089

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Seizalam

Product Details

NDC Product Code
11704-650
Application Number
NDA209566
Marketing Category
NDA (C73594)
Route of Administration
INTRAMUSCULAR
Effective Date
January 26, 2023
MidazolamActive
Code: W7TTW573JJClass: ACTIMQuantity: 5 mg in 1 mL
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
edetate disodiumInactive
Code: 7FLD91C86KClass: IACT
benzyl alcoholInactive
Code: LKG8494WBHClass: IACT
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
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