MedPath
FDA Approval

AMIDATE(TM) ETOMIDATE

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

FDA Approval Summary

Company
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
Effective Date
February 23, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Etomidate(2 mg in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

HF Acquisition Co LLC, DBA HealthFirst

045657305

Manufacturing Establishments1

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

HF Acquisition Co LLC, DBA HealthFirst

HF Acquisition Co LLC, DBA HealthFirst

HF Acquisition Co LLC, DBA HealthFirst

045657305

Products1

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

AMIDATE(TM) ETOMIDATE

Product Details

NDC Product Code
51662-1455
Application Number
NDA018227
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
February 23, 2020
WATERInactive
Code: 059QF0KO0RClass: IACT
EtomidateActive
Code: Z22628B598Class: ACTIBQuantity: 2 mg in 1 mL
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
© Copyright 2025. All Rights Reserved by MedPath