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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021748
Company: SANTARUS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLUMETZA METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
GLUMETZA METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/11/2026 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021748s031lbl.pdf
08/11/2026 SUPPL-31 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021748s031lbl.pdf
11/07/2018 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021748s025lbl.pdf
11/07/2018 SUPPL-25 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021748s025lbl.pdf
04/05/2017 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021748s020lbl.pdf
04/13/2011 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021748s010lbl.pdf
06/16/2009 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021748s005lbl.pdf
11/01/2006 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021748s002lbl.pdf
06/03/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021748lbl.pdf
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