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FDA Approval

Dex-Moxi-Ketor

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

FDA Approval Summary

Company
Imprimis NJOF, LLC
DUNS: 080431967
Effective Date
February 10, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Dexamethasone(1 mg in 1 mL)
Ketorolac(0.4 mg in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Imprimis NJOF, LLC

080431967

Products1

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

Dex-Moxi-Ketor

Product Details

NDC Product Code
71384-513
Route of Administration
OPHTHALMIC
Effective Date
February 10, 2020
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
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