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FDA Approval

DexMoxiKetor PF

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
ImprimisRx NJ
DUNS: 931390178
Effective Date
May 8, 2018
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Dexamethasone(1 mg in 1 mL)
Ketorolac(0.4 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

DexMoxiKetor PF

Product Details

NDC Product Code
70261-513
Route of Administration
INTRAOCULAR
Effective Date
May 8, 2018
Code: AI9376Y64PClass: ACTIRQuantity: 1 mg in 1 mL
KetorolacActive
Code: 4EVE5946BQClass: ACTIMQuantity: 0.4 mg in 1 mL
Code: B8956S8609Class: ACTIMQuantity: 0.5 mg in 1 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

STORAGE AND HANDLING SECTION

Store at 20° to 25° C (68° to 77° F)


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