AMIDATE(TM) ETOMIDATE
AMIDATE(TM) ETOMIDATE INJECTION, USP 40mg/20mL (2mg/mL) 20mL VIAL
Approved
Approval ID
99847797-99eb-40d4-e053-2995a90a972a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 23, 2020
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
AMIDATE(TM) ETOMIDATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51662-1455
Application NumberNDA018227
Product Classification
M
Marketing Category
C73594
G
Generic Name
AMIDATE(TM) ETOMIDATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 23, 2020
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ETOMIDATEActive
Quantity: 2 mg in 1 mL
Code: Z22628B598
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT