Application 020746
- Type
- NDA
- Sponsor
- ASTRAZENECA PHARMS
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RHINOCORT | BUDESONIDE | SPRAY, METERED;NASAL | 0.032MG/INH | Yes | No |
| 002 | RHINOCORT | BUDESONIDE | SPRAY, METERED;NASAL | 0.064MG/INH | No | No |
| 003 | RHINOCORT ALLERGY | BUDESONIDE | SPRAY, METERED;NASAL | 0.032MG/SPRAY | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50580-510 | Childrens RHINOCORT Allergy | Budesonide | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-646 | RHINOCORT Allergy | budesonide | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-646 | RHINOCORT Allergy | budesonide | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-646 | RHINOCORT Allergy | budesonide | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-646 | RHINOCORT Allergy | budesonide | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |