Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
| Prescription | 006 |
| Prescription | 007 |
| Prescription | 008 |
Application Products
| 001 | CAPSULE;ORAL | 5MG | 0 | STRATTERA | ATOMOXETINE HYDROCHLORIDE |
| 002 | CAPSULE;ORAL | 10MG | 1 | STRATTERA | ATOMOXETINE HYDROCHLORIDE |
| 003 | CAPSULE;ORAL | 18MG | 1 | STRATTERA | ATOMOXETINE HYDROCHLORIDE |
| 004 | CAPSULE;ORAL | 25MG | 1 | STRATTERA | ATOMOXETINE HYDROCHLORIDE |
| 005 | CAPSULE;ORAL | 40MG | 1 | STRATTERA | ATOMOXETINE HYDROCHLORIDE |
| 006 | CAPSULE;ORAL | 60MG | 1 | STRATTERA | ATOMOXETINE HYDROCHLORIDE |
| 007 | CAPSULE;ORAL | 80MG | 1 | STRATTERA | ATOMOXETINE HYDROCHLORIDE |
| 008 | CAPSULE;ORAL | 100MG | 1 | STRATTERA | ATOMOXETINE HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2002-11-26 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2005-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2007-04-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2008-05-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2005-05-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2005-02-14 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2005-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2007-04-25 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2007-04-25 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2005-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2007-04-25 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2006-10-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 2007-09-28 | UNKNOWN |
| LABELING; Labeling | SUPPL | 21 | AP | 2007-04-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 24 | AP | 2008-07-23 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2008-07-23 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2008-07-23 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2009-06-03 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2009-06-03 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2010-07-29 | UNKNOWN |
| LABELING; Labeling | SUPPL | 34 | AP | 2012-07-05 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2011-03-07 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2012-08-16 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2012-06-14 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2013-08-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 2013-05-20 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2013-08-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 2014-02-21 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2014-02-20 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2013-12-04 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2015-05-26 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2015-04-17 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2017-05-19 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 49 | AP | 2020-02-25 | STANDARD |
| LABELING; Labeling | SUPPL | 50 | AP | 2022-01-06 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 32 | Null | 7 |
| SUPPL | 34 | Null | 15 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 39 | Null | 7 |
| SUPPL | 40 | Null | 15 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 15 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 15 |
| SUPPL | 45 | Null | 6 |
| SUPPL | 46 | Null | 7 |
| SUPPL | 47 | Null | 7 |
| SUPPL | 48 | Null | 15 |
| SUPPL | 49 | Null | 15 |
| SUPPL | 50 | Null | 6 |
TE Codes
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
| 005 | Prescription | AB |
| 006 | Prescription | AB |
| 007 | Prescription | AB |
| 008 | Prescription | AB |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 21411
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)