MedPath
FDA Product

Ketorolac Tromethamine

Product approved by U.S. Food and Drug Administration (US)

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

KETOROLAC TROMETHAMINE

Quantity: 10 mg in 1 1

Code: 4EVE5946BQ

Class Code: ACTIB

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

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