Documents
Application Sponsors
| NDA 022044 | MERCK SHARP DOHME | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 500MG;EQ 50MG BASE | 1 | JANUMET | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE |
| 002 | TABLET;ORAL | 1GM;EQ 50MG BASE | 1 | JANUMET | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2007-03-30 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2008-01-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2008-02-26 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2008-02-26 | UNKNOWN |
| LABELING; Labeling | SUPPL | 5 | AP | 2008-01-02 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2008-01-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2008-05-01 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2008-10-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2010-02-26 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2009-12-28 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2010-02-26 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2010-02-26 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2010-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2011-06-10 | UNKNOWN |
| LABELING; Labeling | SUPPL | 16 | AP | 2011-04-14 | UNKNOWN |
| LABELING; Labeling | SUPPL | 18 | AP | 2010-09-24 | UNKNOWN |
| LABELING; Labeling | SUPPL | 22 | AP | 2012-03-24 | UNKNOWN |
| LABELING; Labeling | SUPPL | 26 | AP | 2012-10-18 | UNKNOWN |
| LABELING; Labeling | SUPPL | 27 | AP | 2013-02-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2013-06-28 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2013-09-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2014-03-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2015-01-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2015-06-12 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2015-04-27 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2015-08-28 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 39 | AP | 2017-01-18 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 40 | AP | 2017-01-18 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2017-08-10 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2018-02-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 46 | AP | 2019-08-12 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2019-07-01 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 48 | AP | 2020-12-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 51 | AP | 2021-11-04 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2022-06-21 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 2 | Null | 31 |
| SUPPL | 3 | Null | 31 |
| SUPPL | 4 | Null | 31 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 31 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 26 | Null | 7 |
| SUPPL | 27 | Null | 7 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 15 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 15 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 39 | Null | 7 |
| SUPPL | 40 | Null | 7 |
| SUPPL | 42 | Null | 7 |
| SUPPL | 43 | Null | 15 |
| SUPPL | 46 | Null | 7 |
| SUPPL | 47 | Null | 7 |
| SUPPL | 48 | Null | 7 |
| SUPPL | 51 | Null | 15 |
| SUPPL | 52 | Null | 7 |
CDER Filings
MERCK SHARP DOHME
cder:Array
(
[0] => Array
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[companyName] => MERCK SHARP DOHME
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[supplements] =>
[actionDate] => 2019-08-12
)
)