Application 211922
- Type
- ANDA
- Sponsor
- SUN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUDESONIDE | BUDESONIDE | SUSPENSION;INHALATION | 0.25MG/2ML | No | No |
| 002 | BUDESONIDE | BUDESONIDE | SUSPENSION;INHALATION | 0.5MG/2ML | No | No |
| 003 | BUDESONIDE | BUDESONIDE | SUSPENSION;INHALATION | 1MG/2ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47335-631 | Budesonide | Budesonide | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-631 | Budesonide | Budesonide | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-632 | Budesonide | Budesonide | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-632 | Budesonide | Budesonide | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-633 | Budesonide | Budesonide | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-633 | Budesonide | Budesonide | Sun Pharmaceutical Industries, Inc. | ANDA | Current |