Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Direct_Rx
079254320
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Direct_Rx
Direct_Rx
Direct_Rx
079254320
Products1
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
72189-371Application Number
ANDA210616Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 8, 2023POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
KetorolacActive
Code: 4EVE5946BQClass: ACTIBQuantity: 10 mg in 1 1
SHELLACInactive
Code: 46N107B71OClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT