Documents
Application Sponsors
Marketing Status
Application Products
| 001 | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 90MG BASE | 1 | PROZAC WEEKLY | FLUOXETINE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2001-02-26 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2004-08-19 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2005-12-01 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2005-02-18 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2006-04-11 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2006-09-20 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2007-03-15 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2007-08-02 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2008-03-09 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2008-03-21 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2009-01-30 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 15 | AP | 2011-04-04 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2011-04-04 | UNKNOWN |
| LABELING; Labeling | SUPPL | 17 | AP | 2011-04-04 | UNKNOWN |
| LABELING; Labeling | SUPPL | 18 | AP | 2011-06-15 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2013-01-03 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2013-01-03 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2013-07-26 | UNKNOWN |
| LABELING; Labeling | SUPPL | 23 | AP | 2017-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2014-07-18 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 25 | AP | 2015-08-04 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2017-01-04 | 901 REQUIRED |
Submissions Property Types
| SUPPL | 15 | Null | 7 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 21 | Null | 7 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 26 | Null | 15 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 21235
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)