An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 022386
Company: NOVO NORDISK INC

Summary Review

Products on NDA 022386

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRANDIMET	METFORMIN HYDROCHLORIDE; REPAGLINIDE	500MG;1MG	TABLET;ORAL	Discontinued	None	Yes	No
PRANDIMET	METFORMIN HYDROCHLORIDE; REPAGLINIDE	500MG;2MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022386

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/2008	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022386lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022386s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022386_prandimet_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022386s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2017	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022386s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022386Orig1s018ltr.pdf
12/08/2017	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022386s016lbl.pdf
06/04/2014	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/04/2014	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
07/29/2014	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/11/2014	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
10/17/2013	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
10/17/2013	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/24/2012	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022386s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022386s008ltr.pdf
03/01/2012	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022386s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022386s007ltr.pdf
05/28/2010	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022386s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022386s002ltr.pdf

Labels for NDA 022386

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2017	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022386s016lbl.pdf
04/05/2017	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022386s018lbl.pdf
04/24/2012	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022386s000lbl.pdf
03/01/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022386s007lbl.pdf
05/28/2010	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022386s002lbl.pdf
06/23/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022386lbl.pdf

Top