Application 020632
- Type
- NDA
- Sponsor
- ABBOTT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MERIDIA | SIBUTRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 5MG | No | No |
| 002 | MERIDIA | SIBUTRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 10MG | No | No |
| 003 | MERIDIA | SIBUTRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 15MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63741 | SUPPL | 2020-06-26 |
| 43656 | SUPPL | 2010-08-10 |
| 34997 | SUPPL | 2010-08-10 |
| 34996 | SUPPL | 2010-08-10 |
| 25363 | SUPPL | 2010-08-10 |
| 25362 | SUPPL | 2010-08-10 |
| 23170 | SUPPL | 2010-08-10 |
| 12875 | SUPPL | 2009-05-11 |
| 25361 | SUPPL | 2009-05-06 |
| 34995 | SUPPL | 2009-01-02 |
| 25360 | SUPPL | 2008-12-30 |
| 2921 | SUPPL | 2008-05-30 |
| 41497 | SUPPL | 2008-02-19 |
| 41496 | SUPPL | 2008-02-19 |
| 20779 | SUPPL | 2008-02-19 |
| 20778 | SUPPL | 2008-02-19 |
| 20777 | SUPPL | 2008-02-19 |
| 44062 | SUPPL | 2007-07-09 |
| 41498 | SUPPL | 2007-07-09 |
| 2920 | SUPPL | 2006-09-18 |
| 34994 | SUPPL | 2006-08-29 |
| 34992 | SUPPL | 2005-12-15 |
| 2918 | SUPPL | 2005-12-15 |
| 34993 | SUPPL | 2005-08-03 |
| 2919 | SUPPL | 2005-08-03 |
| 12874 | SUPPL | 2004-12-03 |
| 2917 | SUPPL | 2004-12-02 |
| 2916 | SUPPL | 2004-12-02 |
| 25359 | SUPPL | 2003-09-30 |
| 41495 | ORIG | 2003-06-17 |
| 34991 | SUPPL | 2001-02-16 |
| 34990 | SUPPL | 2001-02-16 |
| 25358 | SUPPL | 2001-02-16 |
| 2915 | SUPPL | 2001-02-16 |
| 52198 | SUPPL | 1900-01-01 |
| 52197 | SUPPL | 1900-01-01 |
| 52196 | SUPPL | 1900-01-01 |
| 52195 | SUPPL | 1900-01-01 |
| 52194 | SUPPL | 1900-01-01 |
| 52193 | SUPPL | 1900-01-01 |