Application 021235
- Type
- NDA
- Sponsor
- LILLY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROZAC WEEKLY | FLUOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 90MG BASE | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0002-3004 | Prozac | Fluoxetine hydrochloride | Eli Lilly and Company | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 47756 | SUPPL | 2017-03-29 |
| 47718 | SUPPL | 2017-03-27 |
| 47717 | SUPPL | 2017-03-27 |
| 46820 | SUPPL | 2017-01-13 |
| 46699 | SUPPL | 2017-01-06 |
| 27172 | SUPPL | 2015-08-06 |
| 14711 | SUPPL | 2015-08-06 |
| 4731 | SUPPL | 2014-07-24 |
| 14710 | SUPPL | 2014-07-23 |
| 21532 | SUPPL | 2013-10-23 |
| 27171 | SUPPL | 2013-07-30 |
| 14709 | SUPPL | 2013-07-30 |
| 27170 | SUPPL | 2013-01-07 |
| 14708 | SUPPL | 2013-01-07 |
| 14707 | SUPPL | 2013-01-07 |
| 4730 | SUPPL | 2013-01-07 |
| 4729 | SUPPL | 2011-06-23 |
| 14706 | SUPPL | 2011-06-16 |
| 27169 | SUPPL | 2011-04-13 |
| 27168 | SUPPL | 2011-04-13 |
| 4728 | SUPPL | 2011-04-13 |
| 14705 | SUPPL | 2011-04-04 |
| 14704 | SUPPL | 2011-04-04 |
| 14703 | SUPPL | 2011-04-04 |
| 14702 | SUPPL | 2009-02-04 |
| 4727 | SUPPL | 2009-02-03 |
| 27167 | SUPPL | 2008-03-24 |
| 14701 | SUPPL | 2008-03-24 |
| 14700 | SUPPL | 2008-03-13 |
| 27166 | SUPPL | 2008-03-12 |
| 27165 | SUPPL | 2007-08-07 |
| 14699 | SUPPL | 2007-08-03 |
| 27164 | SUPPL | 2007-03-23 |
| 14698 | SUPPL | 2006-09-21 |
| 4726 | SUPPL | 2006-04-13 |
| 27162 | SUPPL | 2005-12-06 |
| 44107 | ORIG | 2005-08-01 |
| 27163 | SUPPL | 2005-02-23 |
| 21531 | ORIG | 2004-10-18 |
| 4725 | SUPPL | 2004-08-25 |
| 36429 | ORIG | 2001-02-26 |
| 27161 | ORIG | 2001-02-26 |