Application 020155
- Type
- NDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 003 | VIDEX | DIDANOSINE | FOR SOLUTION;ORAL | 100MG/PACKET | No | No |
| 004 | VIDEX | DIDANOSINE | FOR SOLUTION;ORAL | 167MG/PACKET | No | No |
| 005 | VIDEX | DIDANOSINE | FOR SOLUTION;ORAL | 250MG/PACKET | No | No |
| 006 | VIDEX | DIDANOSINE | FOR SOLUTION;ORAL | 375MG/PACKET | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44047 | ORIG | 2010-08-09 |
| 41177 | SUPPL | 2007-11-19 |
| 41172 | SUPPL | 2007-08-06 |
| 20494 | SUPPL | 2007-08-06 |
| 21229 | SUPPL | 2006-12-28 |
| 34321 | SUPPL | 2006-12-04 |
| 2100 | SUPPL | 2006-09-18 |
| 12272 | SUPPL | 2006-08-21 |
| 41176 | SUPPL | 2005-04-27 |
| 41175 | SUPPL | 2005-04-27 |
| 41174 | SUPPL | 2005-04-19 |
| 20496 | SUPPL | 2005-04-19 |
| 20495 | SUPPL | 2005-01-06 |
| 41173 | SUPPL | 2004-08-09 |
| 34319 | SUPPL | 2004-06-30 |
| 2098 | SUPPL | 2004-06-30 |
| 34320 | SUPPL | 2004-01-22 |
| 2099 | SUPPL | 2004-01-22 |
| 34318 | SUPPL | 2003-04-21 |
| 12268 | SUPPL | 2003-04-21 |
| 21228 | SUPPL | 2003-03-10 |
| 12271 | SUPPL | 2003-03-07 |
| 21227 | SUPPL | 2002-09-25 |
| 12270 | SUPPL | 2002-09-25 |
| 12269 | SUPPL | 2002-04-01 |
| 2097 | SUPPL | 2002-04-01 |
| 34317 | SUPPL | 1999-10-29 |
| 21226 | SUPPL | 1999-10-29 |