Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021202
Company: EMD SERONO INC
Company: EMD SERONO INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GLUCOPHAGE XR | METFORMIN HYDROCHLORIDE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
GLUCOPHAGE XR | METFORMIN HYDROCHLORIDE | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
10/13/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21202lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21202ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-202_Glucophage.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/05/2017 | SUPPL-23 | 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-21 | 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 | |
03/05/2014 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/31/2014 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/30/2018 | SUPPL-18 | 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-16 | 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-15 | 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-13 | 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-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20357slr026,027,21202slr011,013ltr.pdf |
04/11/2003 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21202scf008_glucophage_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21202scs008ltr.pdf | |
06/06/2002 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
07/02/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/08/2002 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/08/2002 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21202s3ltr.pdf |
07/31/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/19/2001 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21202S1ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/30/2018 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020357s034,021202s018lbl.pdf | |
04/05/2017 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf | |
04/05/2017 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf | |
08/27/2008 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020357s031,021202s016lbl.pdf | |
11/01/2006 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020357s030,021202s015lbl.pdf | |
04/11/2003 | SUPPL-8 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21202scf008_glucophage_lbl.pdf | |
10/13/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21202lbl.pdf |