KETOROLAC TROMETHAMINE

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Steriscience Pte. Limited

DUNS Number

659844097

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Steriscience Specialties Private Limited

Labeler

Steriscience Specialties Private Limited

Registrant

Steriscience Pte. Limited

DUNS Number

676199117

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

82449-217

Application Number

ANDA078299

Marketing Category

ANDA (C73584)

Route of Administration

INTRAMUSCULAR

Effective Date

July 5, 2023

Ingredients

KetorolacActive

Code: 4EVE5946BQClass: ACTIBQuantity: 60 mg in 2 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT