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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
Effective Date
December 6, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Etomidate(2 mg in 1 mL)

Manufacturing Establishments1

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

HIKMA FARMACEUTICA (PORTUGAL), S.A

Hikma Pharmaceuticals USA Inc.

452742943

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
0143-9507
Application Number
ANDA202354
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
December 6, 2023
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
EtomidateActive
Code: Z22628B598Class: ACTIBQuantity: 2 mg in 1 mL

Etomidate

Product Details

NDC Product Code
0143-9506
Application Number
ANDA202354
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
December 6, 2023
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
EtomidateActive
Code: Z22628B598Class: ACTIBQuantity: 2 mg in 1 mL
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