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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "021135."



Active Ingredient: IRON SUCROSE
Dosage Form;Route: INJECTABLE;INTRAVENOUS
Proprietary Name: VENOFER
Applicant: LUITPOLD
Strength: EQ 100MG BASE/5ML (EQ 20MG BASE/ML)
Application Number: N021135
Product Number: 001
Approval Date: Nov 6, 2000
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: IRON SUCROSE
Dosage Form;Route: INJECTABLE;INTRAVENOUS
Proprietary Name: VENOFER
Applicant: LUITPOLD
Strength: EQ 50MG BASE/2.5ML (EQ 20MG BASE/ML)
Application Number: N021135
Product Number: 002
Approval Date: Mar 20, 2005
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: IRON SUCROSE
Dosage Form;Route: INJECTABLE;INTRAVENOUS
Proprietary Name: VENOFER
Applicant: LUITPOLD
Strength: EQ 200MG BASE/10ML (EQ 20MG BASE/ML)
Application Number: N021135
Product Number: 004
Approval Date: Feb 9, 2007
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through September 2014
Patent and Generic Drug Product Data Last Updated October 22, 2014

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