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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
October 9, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ketorolac(10 mg in 1 1)

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
0378-1134
Application Number
ANDA074761
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 13, 2015
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
KetorolacActive
Code: 4EVE5946BQClass: ACTIBQuantity: 10 mg in 1 1
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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