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FDA Approval

KETOROLAC TROMETHAMINE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
July 4, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ketorolac(15 mg in 1 mL)

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
31722-305
Application Number
ANDA217166
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR
Effective Date
July 4, 2023
ANHYDROUS 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
31722-306
Application Number
ANDA217166
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR
Effective Date
July 4, 2023
HYDROCHLORIC 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
31722-307
Application Number
ANDA217166
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR
Effective Date
July 4, 2023
ALCOHOLInactive
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
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