Drugs@FDA: FDA Approved Drug Products

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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 TABLET;ORAL Discontinued None Yes No
GLUCOPHAGE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Discontinued None Yes No
GLUCOPHAGE METFORMIN HYDROCHLORIDE 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
GLUCOPHAGE METFORMIN HYDROCHLORIDE 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
GLUCOPHAGE METFORMIN HYDROCHLORIDE 1GM TABLET;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/03/1995 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020357Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/05/2017 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020357Orig1s037s039,021202Orig1s021s023ltr.pdf
04/05/2017 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020357Orig1s037s039,021202Orig1s021s023ltr.pdf
11/13/2013 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

03/14/2013 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

05/30/2018 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020357s034,021202s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020357Orig1s034, 021202Orig1s018ltr.pdf
08/27/2008 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020357s031,021202s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020357s031, 021202s016ltr.pdf
11/01/2006 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020357s030,021202s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020357s030,021202s015ltr.pdf
03/19/2004 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20357slr026,027,21202slr011,013ltr.pdf
03/19/2004 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20357slr026,027,21202slr011,013ltr.pdf
01/08/2002 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21202s3ltr.pdf
02/08/2001 SUPPL-22 Labeling

Label is not available on this site.

08/04/2000 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/19/2001 SUPPL-20 Efficacy-Labeling Change With Clinical Data Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20357S20ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020357_S020_GLUCOPHAGE_AP.pdf
12/15/2000 SUPPL-19 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20357S019_Glucophage_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20357S19LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20357s19_glucophage.cfm
06/07/1999 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1999 SUPPL-17 Efficacy-Labeling Change With Clinical Data Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20357S17.PDF
03/12/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/01/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/04/1998 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/05/1998 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/22/1998 SUPPL-10 Efficacy-New Indication Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20357s10ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020357s010.cfm
07/02/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/10/1998 SUPPL-8 Labeling

Label is not available on this site.

05/15/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/06/1997 SUPPL-6 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020357a_s006.pdf
06/06/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/26/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/30/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1995 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

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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