Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
ASCLEMED USA INC. DBA ENOVACHEM
Asclemed USA, Inc.
059888437
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ketorolac Tromethamine
Product Details
NDC Product Code
76420-184Application Number
ANDA074802Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
October 12, 2022WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8.7 mg in 2 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
KetorolacActive
Code: 4EVE5946BQClass: ACTIBQuantity: 60 mg in 2 mL