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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203565

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INJECTAFER (FERRIC CARBOXYMALTOSE)
750MG IRON/15ML (50MG IRON/ML)
Marketing Status: Prescription
Active Ingredient: FERRIC CARBOXYMALTOSE
Proprietary Name: INJECTAFER
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 750MG IRON/15ML (50MG IRON/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203565
Product Number: 001
Approval Date: Jul 25, 2013
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information
INJECTAFER (FERRIC CARBOXYMALTOSE)
100MG IRON/2ML (50MG IRON/ML)
Marketing Status: Prescription
Active Ingredient: FERRIC CARBOXYMALTOSE
Proprietary Name: INJECTAFER
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MG IRON/2ML (50MG IRON/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203565
Product Number: 004
Approval Date: Feb 4, 2022
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information
INJECTAFER (FERRIC CARBOXYMALTOSE)
500MG IRON/10ML (50MG IRON/ML)
Marketing Status: Prescription
Active Ingredient: FERRIC CARBOXYMALTOSE
Proprietary Name: INJECTAFER
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 500MG IRON/10ML (50MG IRON/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203565
Product Number: 002
Approval Date: Oct 8, 2020
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information
INJECTAFER (FERRIC CARBOXYMALTOSE)
1GM IRON/20ML (50MG IRON/ML)
Marketing Status: Prescription
Active Ingredient: FERRIC CARBOXYMALTOSE
Proprietary Name: INJECTAFER
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM IRON/20ML (50MG IRON/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203565
Product Number: 003
Approval Date: Apr 28, 2021
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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