Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 004 |
Application Products
| 001 | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | 1 | CYMBALTA | DULOXETINE HYDROCHLORIDE |
| 002 | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 30MG BASE | 1 | CYMBALTA | DULOXETINE HYDROCHLORIDE |
| 004 | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 60MG BASE | 1 | CYMBALTA | DULOXETINE HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2004-08-03 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2005-02-18 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2006-06-06 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2007-02-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2007-02-23 | UNKNOWN |
| LABELING; Labeling | SUPPL | 12 | AP | 2006-09-20 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2007-02-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2007-11-28 | UNKNOWN |
| LABELING; Labeling | SUPPL | 17 | AP | 2007-11-28 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2007-08-02 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2009-03-18 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2009-03-18 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2009-03-18 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2009-01-30 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 30 | AP | 2009-11-19 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2011-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2012-08-24 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2011-04-12 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2014-11-25 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2012-08-24 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2011-09-02 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 40 | AP | 2012-10-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 41 | AP | 2012-10-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 42 | AP | 2014-11-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 43 | AP | 2014-10-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 44 | AP | 2014-10-16 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2014-07-17 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 46 | AP | 2015-06-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 2016-07-12 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2016-09-02 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 49 | AP | 2017-01-04 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 50 | AP | 2017-12-19 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 51 | AP | 2019-10-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 52 | AP | 2020-04-20 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2020-10-01 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 2021-09-20 | 901 REQUIRED |
Submissions Property Types
| SUPPL | 30 | Null | 7 |
| SUPPL | 31 | Null | 6 |
| SUPPL | 32 | Null | 6 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 37 | Null | 6 |
| SUPPL | 38 | Null | 6 |
| SUPPL | 39 | Null | 7 |
| SUPPL | 40 | Null | 7 |
| SUPPL | 41 | Null | 8 |
| SUPPL | 42 | Null | 6 |
| SUPPL | 43 | Null | 6 |
| SUPPL | 44 | Null | 7 |
| SUPPL | 45 | Null | 7 |
| SUPPL | 46 | Null | 15 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 48 | Null | 6 |
| SUPPL | 49 | Null | 6 |
| SUPPL | 50 | Null | 7 |
| SUPPL | 51 | Null | 33 |
| SUPPL | 52 | Null | 6 |
| SUPPL | 53 | Null | 6 |
| SUPPL | 56 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
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(
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