Application 208851
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUDESONIDE | BUDESONIDE | TABLET, EXTENDED RELEASE;ORAL | 9MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-4500 | Budesonide | Budesonide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4500 | Budesonide | Budesonide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4500 | Budesonide | Budesonide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 51407-366 | Budesonide | Budesonide | Golden State Medical Supply, Inc. | ANDA | Current |