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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 30, 2020
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.

Caplin Steriles Limited

Caplin Steriles Limited

650744670

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
65145-127
Application Number
ANDA215028
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
December 30, 2020
EtomidateActive
Code: Z22628B598Class: ACTIBQuantity: 2 mg in 1 mL
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Etomidate

Product Details

NDC Product Code
65145-128
Application Number
ANDA215028
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
December 30, 2020
WATERInactive
Code: 059QF0KO0RClass: IACT
EtomidateActive
Code: Z22628B598Class: ACTIBQuantity: 2 mg in 1 mL
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
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