➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Merck
Express Scripts
McKinsey
Medtronic

Last Updated: September 21, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020955


Email this page to a colleague

« Back to Dashboard

NDA 020955 describes FERRLECIT, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. Additional details are available on the FERRLECIT profile page.

The generic ingredient in FERRLECIT is ferric oxyhydroxide. There are twenty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ferric oxyhydroxide profile page.
Summary for 020955
Tradename:FERRLECIT
Applicant:Sanofi Aventis Us
Ingredient:ferric oxyhydroxide
Patents:0
Pharmacology for NDA: 020955
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 020955
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FERRLECIT ferric oxyhydroxide INJECTABLE;INJECTION 020955 NDA sanofi-aventis U.S. LLC 0024-2792 0024-2792-10 10 VIAL, SINGLE-USE in 1 CARTON (0024-2792-10) > 5 mL in 1 VIAL, SINGLE-USE (0024-2792-01)
FERRLECIT ferric oxyhydroxide INJECTABLE;INJECTION 020955 NDA sanofi-aventis U.S. LLC 0024-2794 0024-2794-10 10 VIAL, SINGLE-USE in 1 CARTON (0024-2794-10) > 5 mL in 1 VIAL, SINGLE-USE (0024-2794-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)
Approval Date:Feb 18, 1999TE:ABRLD:Yes

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Merck
Colorcon
AstraZeneca
Medtronic
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.