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FDA Approval

ETOMIDATE

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

FDA Approval Summary

Company
Eugia US LLC
DUNS: 968961354
Effective Date
July 5, 2023
Labeling Type
Human Prescription Drug Label
Etomidate(40 mg in 20 mL)

Manufacturing Establishments1

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

Eugia Pharma Specialities Limited

Eugia US LLC

650498244

Products2

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

ETOMIDATE

Product Details

NDC Product Code
55150-222
Application Number
ANDA206126
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
July 5, 2023
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
EtomidateActive
Code: Z22628B598Class: ACTIBQuantity: 40 mg in 20 mL
WATERInactive
Code: 059QF0KO0RClass: IACT

ETOMIDATE

Product Details

NDC Product Code
55150-221
Application Number
ANDA206126
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
July 5, 2023
EtomidateActive
Code: Z22628B598Class: ACTIBQuantity: 20 mg in 10 mL
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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