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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
November 14, 2022
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.

Zydus Pharmaceuticals USA Inc.

156861945

Manufacturing Establishments1

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

Zydus Lifesciences Limited

Zydus Pharmaceuticals USA Inc.

Zydus Pharmaceuticals USA Inc.

918596198

Products1

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
68382-545
Application Number
ANDA202360
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
November 14, 2022
EtomidateActive
Code: Z22628B598Class: ACTIBQuantity: 2 mg in 1 mL
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACTQuantity: 0.35 mL in 1 mL
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