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
68382-545Application Number
ANDA202360Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
November 14, 2022EtomidateActive
Code: Z22628B598Class: ACTIBQuantity: 2 mg in 1 mL
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACTQuantity: 0.35 mL in 1 mL