Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021591
Company: RANBAXY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIOMET METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION;ORAL 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
10/20/2008 ORIG-4 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

09/11/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21591_riomet_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21591ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-591_Riomet.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/05/2017 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021591s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021591Orig1s010ltr.pdf
08/29/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/06/2018 SUPPL-7 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021591s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021591Orig1s007ltr.pdf
09/16/2013 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/06/2010 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021591s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021591s005ltr.pdf
10/20/2008 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021591s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021591s004ltr.pdf
09/20/2005 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021591s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021591s003ltr.pdf
06/02/2004 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21591slr001_riomet_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21591slr001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/06/2018 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021591s007lbl.pdf
11/06/2018 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021591s007lbl.pdf
04/05/2017 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021591s010lbl.pdf
12/06/2010 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021591s005lbl.pdf
10/20/2008 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021591s004lbl.pdf
09/20/2005 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021591s003lbl.pdf
06/02/2004 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21591slr001_riomet_lbl.pdf
09/11/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21591_riomet_lbl.pdf

RIOMET

SOLUTION;ORAL; 500MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION;ORAL Prescription No AB 211309 SAPTALIS PHARMS
RIOMET METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION;ORAL Prescription Yes AB 021591 RANBAXY

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