Basic Information
Ketorolac Tromethamine
35573-450
Regulatory Information
35573-450
ANDA210616
C73584
March 15, 2023
USA
KETOROLAC TROMETHAMINE- ketorolac tromethamine tablet, film coated Burel Pharmaceuticals, LLC Rx only
HUMAN PRESCRIPTION DRUG LABEL
4
Company Information
609436204
Active Ingredients
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
HYPROMELLOSE 2910 (6 MPA.S)
Code: 0WZ8WG20P6
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
HYPROMELLOSE 2910 (3 MPA.S)
Code: 0VUT3PMY82
Class Code: IACT
POLYETHYLENE GLYCOL 400
Code: B697894SGQ
Class Code: IACT
POLYSORBATE 80
Code: 6OZP39ZG8H
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
ISOPROPYL ALCOHOL
Code: ND2M416302
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
BUTYL ALCOHOL
Code: 8PJ61P6TS3
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
WATER
Code: 059QF0KO0R
Class Code: IACT
AMMONIA
Code: 5138Q19F1X
Class Code: IACT
Active Moieties
KETOROLAC
Code: YZI5105V0L