KETOROLAC TROMETHAMINE
Ketorolac Tromethamine Ophthalmic Solution, 0.5%
Approved
Approval ID
b5f5bdb5-2a0e-437e-a6da-aa262cdc9b89
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
KETOROLAC TROMETHAMINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-376
Application NumberANDA078434
Product Classification
M
Marketing Category
C73584
G
Generic Name
KETOROLAC TROMETHAMINE
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 1, 2010
FDA Product Classification
INGREDIENTS (8)
KETOROLAC TROMETHAMINEActive
Quantity: 5 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
OCTOXYNOL-40Inactive
Code: 9T1C662FKS
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT