Documents
Application Sponsors
Marketing Status
Application Products
| 001 | GRANULE;ORAL | EQ 4MG BASE/PACKET | 1 | SINGULAIR | MONTELUKAST SODIUM |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2002-07-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2002-12-31 | UNKNOWN |
| LABELING; Labeling | SUPPL | 5 | AP | 2003-10-02 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2003-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2004-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2004-12-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2005-07-27 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2005-11-30 | UNKNOWN |
| LABELING; Labeling | SUPPL | 15 | AP | 2005-05-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2007-04-13 | UNKNOWN |
| LABELING; Labeling | SUPPL | 17 | AP | 2005-06-27 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2006-05-19 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2006-12-08 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2008-03-07 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2008-04-21 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2008-04-24 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2009-01-27 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2009-08-19 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2010-04-26 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2010-08-10 | UNKNOWN |
| LABELING; Labeling | SUPPL | 34 | AP | 2011-04-27 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 36 | AP | 2012-03-26 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2011-12-16 | UNKNOWN |
| LABELING; Labeling | SUPPL | 39 | AP | 2012-10-18 | UNKNOWN |
| LABELING; Labeling | SUPPL | 40 | AP | 2012-09-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 42 | AP | 2013-03-21 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2013-12-30 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2014-11-26 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2016-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2018-12-21 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2018-12-21 | STANDARD |
| LABELING; Labeling | SUPPL | 50 | AP | 2019-08-09 | STANDARD |
| LABELING; Labeling | SUPPL | 51 | AP | 2020-04-29 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2021-02-22 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 8 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 31 | Null | 7 |
| SUPPL | 34 | Null | 6 |
| SUPPL | 36 | Null | 7 |
| SUPPL | 37 | Null | 15 |
| SUPPL | 39 | Null | 15 |
| SUPPL | 40 | Null | 6 |
| SUPPL | 42 | Null | 15 |
| SUPPL | 43 | Null | 15 |
| SUPPL | 45 | Null | 15 |
| SUPPL | 47 | Null | 15 |
| SUPPL | 48 | Null | 6 |
| SUPPL | 49 | Null | 6 |
| SUPPL | 50 | Null | 6 |
| SUPPL | 51 | Null | 7 |
| SUPPL | 52 | Null | 7 |
TE Codes
CDER Filings
cder:Array
(
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[companyName] =>
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[labels] =>
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)
)