Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aspiro Pharma Limited
Camber Pharmaceuticals, Inc.
872341023
Products3
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
31722-305Application Number
ANDA217166Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
July 4, 2023ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 6.68 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
KetorolacActive
Code: 4EVE5946BQClass: ACTIBQuantity: 15 mg in 1 mL
KETOROLAC TROMETHAMINE
Product Details
NDC Product Code
31722-306Application Number
ANDA217166Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
July 4, 2023HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 6.68 mg in 1 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
KetorolacActive
Code: 4EVE5946BQClass: ACTIBQuantity: 30 mg in 1 mL
KETOROLAC TROMETHAMINE
Product Details
NDC Product Code
31722-307Application Number
ANDA217166Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
July 4, 2023ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
KetorolacActive
Code: 4EVE5946BQClass: ACTIBQuantity: 60 mg in 1 mL