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FDA Drug Approval, N212045, KLOXXADO
FDA Drug Approval, N212045, KLOXXADO
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NDA: 212045
Company: HIKMA
Drug Name: KLOXXADO
Active Ingredients: NALOXONE HYDROCHLORIDE
Strength: 8MG/SPRAY
Dosage Form/Route: SPRAY;NASAL
Action Date: 04/29/2021
Marketing Status: Prescription
Submission Classification: Type 5 - New Formulation or New Manufacturer
Company: HIKMA
Drug Name: KLOXXADO
Active Ingredients: NALOXONE HYDROCHLORIDE
Strength: 8MG/SPRAY
Dosage Form/Route: SPRAY;NASAL
Action Date: 04/29/2021
Marketing Status: Prescription
Submission Classification: Type 5 - New Formulation or New Manufacturer
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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