Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 500MG | 1 | GLUMETZA | METFORMIN HYDROCHLORIDE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 1GM | 1 | GLUMETZA | METFORMIN HYDROCHLORIDE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2005-06-03 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2006-11-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2007-12-28 | N/A |
| LABELING; Labeling | SUPPL | 5 | AP | 2009-06-16 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2010-02-25 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2011-04-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2015-10-27 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2017-04-05 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 25 | AP | 2018-11-07 | STANDARD |
Submissions Property Types
| SUPPL | 8 | Null | 7 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 25 | Null | 15 |
TE Codes
| 001 | Prescription | AB3 |
| 002 | Prescription | AB3 |
CDER Filings
SANTARUS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 21748
[companyName] => SANTARUS INC
[docInserts] => ["",""]
[products] => [{"drugName":"GLUMETZA","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"GLUMETZA","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"11\/07\/2018","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021748s025lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2018","submission":"SUPPL-25","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021748s025lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021748s020lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2011","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021748s010lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2009","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021748s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2006","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021748s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/03\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021748lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"GLUMETZA","submission":"METFORMIN HYDROCHLORIDE","actionType":"500MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"GLUMETZA","submission":"METFORMIN HYDROCHLORIDE","actionType":"1GM","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-11-07
)
)