Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
| Discontinued | 005 |
Application Products
| 001 | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE |
| 002 | TABLET;ORAL | 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE |
| 003 | TABLET;ORAL | 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE |
| 004 | TABLET;ORAL | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE |
| 005 | TABLET;ORAL | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1995-03-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1995-09-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1996-04-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1996-07-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1997-06-06 | PRIORITY |
| LABELING; Labeling | SUPPL | 6 | AP | 1997-11-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1998-05-15 | PRIORITY |
| LABELING; Labeling | SUPPL | 8 | AP | 1998-02-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1998-07-02 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 1998-10-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1998-11-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1998-11-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1998-12-04 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1999-06-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1999-03-12 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 1999-09-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1999-06-07 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 2000-12-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 2001-04-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2000-08-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 22 | AP | 2001-02-08 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2002-01-08 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2004-03-19 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2004-03-19 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2006-11-01 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2008-08-27 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2018-05-30 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2013-03-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2013-11-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 37 | AP | 2017-04-05 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2017-04-05 | 901 REQUIRED |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 8 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 34 | Null | 6 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 6 |
| SUPPL | 39 | Null | 15 |
CDER Filings
EMD SERONO INC
cder:Array
(
[0] => Array
(
[ApplNo] => 20357
[companyName] => EMD SERONO INC
[docInserts] => ["",""]
[products] => [{"drugName":"GLUCOPHAGE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"GLUCOPHAGE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"850MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"GLUCOPHAGE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"625MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"GLUCOPHAGE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"750MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"GLUCOPHAGE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"1GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"05\/30\/2018","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020357s034,021202s018lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020357s037s039,021202s021s023lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020357s037s039,021202s021s023lbl.pdf\"}]","notes":""},{"actionDate":"08\/27\/2008","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020357s031,021202s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2006","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020357s030,021202s015lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2000","submission":"SUPPL-19","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2000\\\/20357S019_Glucophage_prntlbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"GLUCOPHAGE","submission":"METFORMIN HYDROCHLORIDE","actionType":"500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"GLUCOPHAGE","submission":"METFORMIN HYDROCHLORIDE","actionType":"850MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"GLUCOPHAGE","submission":"METFORMIN HYDROCHLORIDE","actionType":"625MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"GLUCOPHAGE","submission":"METFORMIN HYDROCHLORIDE","actionType":"750MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"GLUCOPHAGE","submission":"METFORMIN HYDROCHLORIDE","actionType":"1GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-05-30
)
)