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FDA Drug Approval, N203565, INJECTAFER
FDA Drug Approval, N203565, INJECTAFER
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NDA: 203565
Company: AM REGENT
Drug Name: INJECTAFER
Active Ingredients: FERRIC CARBOXYMALTOSE
Strength: 100MG IRON/2ML (50MG IRON/ML)
Dosage Form/Route: SOLUTION;INTRAVENOUS
Action Date: 07/25/2013
Marketing Status: Prescription
Submission Classification: Type 5 - New Formulation or New Manufacturer
Company: AM REGENT
Drug Name: INJECTAFER
Active Ingredients: FERRIC CARBOXYMALTOSE
Strength: 100MG IRON/2ML (50MG IRON/ML)
Dosage Form/Route: SOLUTION;INTRAVENOUS
Action Date: 07/25/2013
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
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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