Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 004 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | GLUCOPHAGE XR | METFORMIN HYDROCHLORIDE |
| 004 | TABLET, EXTENDED RELEASE;ORAL | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | GLUCOPHAGE XR | METFORMIN HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2000-10-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2001-07-31 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2002-01-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-01-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2002-07-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2002-06-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2003-04-11 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2004-03-19 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2004-03-19 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2006-11-01 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2008-08-27 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2018-05-30 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2014-01-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2014-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2017-04-05 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2017-04-05 | 901 REQUIRED |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 15 |
| SUPPL | 23 | Null | 15 |
CDER Filings
EMD SERONO INC
cder:Array
(
[0] => Array
(
[ApplNo] => 21202
[companyName] => EMD SERONO INC
[docInserts] => ["",""]
[products] => [{"drugName":"GLUCOPHAGE XR","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"GLUCOPHAGE XR","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"750MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"05\/30\/2018","submission":"SUPPL-18","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-23","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-21","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-16","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-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020357s030,021202s015lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2003","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21202scf008_glucophage_lbl.pdf\"}]","notes":""},{"actionDate":"10\/13\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21202lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"GLUCOPHAGE XR","submission":"METFORMIN HYDROCHLORIDE","actionType":"500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"GLUCOPHAGE XR","submission":"METFORMIN HYDROCHLORIDE","actionType":"750MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-05-30
)
)