MedPath

Etomidate

Etomidate Injection, USP For intravenous use

Approved
Approval ID

75467058-da52-48fa-8d4e-e1025ec7d461

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 22, 2024

Manufacturers
FDA

Armas Pharmaceuticals Inc.

DUNS: 098405973

Products 2

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

Etomidate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72485-509
Application NumberANDA215028
Product Classification
M
Marketing Category
C73584
G
Generic Name
Etomidate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 22, 2024
FDA Product Classification

INGREDIENTS (3)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ETOMIDATEActive
Quantity: 2 mg in 1 mL
Code: Z22628B598
Classification: ACTIB

Etomidate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72485-508
Application NumberANDA215028
Product Classification
M
Marketing Category
C73584
G
Generic Name
Etomidate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 22, 2024
FDA Product Classification

INGREDIENTS (3)

ETOMIDATEActive
Quantity: 2 mg in 1 mL
Code: Z22628B598
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

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