Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Armas Pharmaceuticals Inc.
098405973
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Caplin Steriles Limited
Armas Pharmaceuticals Inc.
Armas Pharmaceuticals Inc.
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
72485-509Application Number
ANDA215028Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
January 22, 2024WATERInactive
Code: 059QF0KO0RClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
EtomidateActive
Code: Z22628B598Class: ACTIBQuantity: 2 mg in 1 mL
Etomidate
Product Details
NDC Product Code
72485-508Application Number
ANDA215028Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
January 22, 2024EtomidateActive
Code: Z22628B598Class: ACTIBQuantity: 2 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT