Application 021046
- Type
- NDA
- Sponsor
- FOREST LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CELEXA | CITALOPRAM HYDROBROMIDE | SOLUTION;ORAL | EQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44091 | ORIG | 2016-04-11 |
| 41904 | SUPPL | 2013-09-11 |
| 4164 | SUPPL | 2012-12-05 |
| 14246 | SUPPL | 2012-12-03 |
| 35980 | SUPPL | 2012-03-29 |
| 4163 | SUPPL | 2012-03-29 |
| 41903 | SUPPL | 2011-10-11 |
| 21389 | SUPPL | 2011-10-11 |
| 4162 | SUPPL | 2011-08-17 |
| 4161 | SUPPL | 2011-08-17 |
| 35979 | SUPPL | 2011-08-16 |
| 35978 | SUPPL | 2011-08-16 |
| 43698 | ORIG | 2009-11-16 |
| 14245 | SUPPL | 2009-02-04 |
| 26591 | SUPPL | 2009-02-03 |
| 35977 | SUPPL | 2008-09-19 |
| 26590 | SUPPL | 2008-09-19 |
| 26589 | SUPPL | 2007-08-07 |
| 35976 | SUPPL | 2007-08-03 |
| 4160 | SUPPL | 2005-02-23 |
| 4159 | SUPPL | 2004-05-26 |
| 4158 | SUPPL | 2004-04-20 |
| 4157 | SUPPL | 2002-11-19 |
| 26588 | ORIG | 1999-12-22 |
| 21388 | ORIG | 1999-12-22 |