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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021135

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VENOFER (FERRIC OXYHYDROXIDE)
EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)
Marketing Status: Prescription
Active Ingredient: FERRIC OXYHYDROXIDE
Proprietary Name: VENOFER
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021135
Product Number: 002
Approval Date: Mar 20, 2005
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VENOFER (FERRIC OXYHYDROXIDE)
EQ 100MG IRON/5ML (EQ 20MG IRON/ML)
Marketing Status: Prescription
Active Ingredient: FERRIC OXYHYDROXIDE
Proprietary Name: VENOFER
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 100MG IRON/5ML (EQ 20MG IRON/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021135
Product Number: 001
Approval Date: Nov 6, 2000
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VENOFER (FERRIC OXYHYDROXIDE)
EQ 200MG IRON/10ML (EQ 20MG IRON/ML)
Marketing Status: Prescription
Active Ingredient: FERRIC OXYHYDROXIDE
Proprietary Name: VENOFER
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 200MG IRON/10ML (EQ 20MG IRON/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021135
Product Number: 004
Approval Date: Feb 9, 2007
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VENOFER (FERRIC OXYHYDROXIDE)
EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)
Marketing Status: Discontinued
Active Ingredient: FERRIC OXYHYDROXIDE
Proprietary Name: VENOFER
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021135
Product Number: 005
Approval Date: Mar 29, 2013
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
VENOFER (FERRIC OXYHYDROXIDE)
EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)
Marketing Status: Discontinued
Active Ingredient: FERRIC OXYHYDROXIDE
Proprietary Name: VENOFER
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021135
Product Number: 003
Approval Date: Mar 29, 2005
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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