Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020357
Company: EMD SERONO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLUCOPHAGE METFORMIN HYDROCHLORIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
GLUCOPHAGE METFORMIN HYDROCHLORIDE 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
GLUCOPHAGE METFORMIN HYDROCHLORIDE 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
GLUCOPHAGE METFORMIN HYDROCHLORIDE 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
GLUCOPHAGE METFORMIN HYDROCHLORIDE 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/30/2018 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020357s034,021202s018lbl.pdf
04/05/2017 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf
04/05/2017 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf
08/27/2008 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020357s031,021202s016lbl.pdf
11/01/2006 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020357s030,021202s015lbl.pdf
12/15/2000 SUPPL-19 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20357S019_Glucophage_prntlbl.pdf

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