Application 020441
- Type
- NDA
- Sponsor
- ASTRAZENECA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | PULMICORT | BUDESONIDE | POWDER, METERED;INHALATION | 0.16MG/INH | No | No |
| 003 | PULMICORT | BUDESONIDE | POWDER, METERED;INHALATION | 0.32MG/INH | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 41363 | SUPPL | 2007-11-19 |
| 41362 | SUPPL | 2007-11-19 |
| 41361 | SUPPL | 2007-11-19 |
| 41360 | SUPPL | 2007-11-19 |
| 20659 | SUPPL | 2007-11-19 |
| 20658 | SUPPL | 2007-11-19 |
| 20657 | SUPPL | 2007-11-19 |
| 20656 | SUPPL | 2007-11-19 |
| 20655 | SUPPL | 2007-11-19 |
| 24969 | SUPPL | 2007-08-22 |
| 12580 | SUPPL | 2007-08-21 |
| 41365 | SUPPL | 2007-07-09 |
| 41364 | SUPPL | 2007-07-09 |
| 41366 | SUPPL | 2007-07-06 |
| 20660 | SUPPL | 2007-04-11 |
| 34652 | SUPPL | 2003-12-29 |
| 24968 | SUPPL | 2003-12-22 |
| 34651 | SUPPL | 2003-11-05 |
| 24967 | SUPPL | 2003-11-05 |
| 34653 | SUPPL | 2003-09-30 |
| 2536 | SUPPL | 2003-09-30 |
| 2535 | SUPPL | 2001-12-31 |
| 41359 | SUPPL | 1998-10-08 |
| 34650 | SUPPL | 1998-10-08 |
| 24966 | SUPPL | 1998-10-08 |