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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021591
Company: RANBAXY

Products on NDA 021591

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIOMET	METFORMIN HYDROCHLORIDE	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021591

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

Labels for NDA 021591

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

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