Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020955
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FERRLECIT SODIUM FERRIC GLUCONATE COMPLEX 62.5MG/5ML INJECTABLE;INJECTION Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/18/1999 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20955lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20955ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20955_Ferrlecit.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/01/2013 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/25/2011 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020955s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020955Orig1s013,s015ltr.pdf
08/25/2011 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020955s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020955Orig1s013,s015ltr.pdf
10/02/2006 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020955s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020955s010LTR.pdf
08/13/2004 SUPPL-6 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20955s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20955s006ltr.pdf
06/07/2002 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20955s005ltr.pdf
04/09/2002 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/02/2001 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20955s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20955s3ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020955_S003_FERRLECIT_AP.pdf
07/27/1999 SUPPL-1 Manufacturing (CMC)-Expiration Date Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020955_S001_FERRLECIT_AP.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/25/2011 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020955s013s015lbl.pdf
08/25/2011 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020955s013s015lbl.pdf
10/02/2006 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020955s010lbl.pdf
08/13/2004 SUPPL-6 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20955s006lbl.pdf
02/02/2001 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20955s3lbl.pdf
02/18/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20955lbl.pdf

FERRLECIT

INJECTABLE;INJECTION; 62.5MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FERRLECIT SODIUM FERRIC GLUCONATE COMPLEX 62.5MG/5ML INJECTABLE;INJECTION Prescription Yes AB 020955 SANOFI AVENTIS US
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE SODIUM FERRIC GLUCONATE COMPLEX 62.5MG/5ML INJECTABLE;INJECTION Prescription No AB 078215 WEST-WARD PHARMS INT

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English