Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
  • Print
  • Share
  • E-mail
-

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
Active Ingredient: IRON SUCROSE
Dosage Form;Route: INJECTABLE; INTRAVENOUS
Proprietary Name: VENOFER
Applicant: LUITPOLD
Strength: EQ 65MG BASE/3.25ML (EQ 20MG BASE/ML)
Application Number: N021135
Product Number: 005
Approval Date: Mar 29, 2013
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Return to Electronic Orange Book Home Page

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 April, 2013
    Patent and Generic Drug Product Data Last Updated: May 23, 2013
-
-