Application 090379
- Type
- ANDA
- Sponsor
- BARR LABS DIV TEVA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BUDESONIDE | BUDESONIDE | CAPSULE;ORAL | 3MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0093-7445 | Budesonide | Budesonide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7445 | Budesonide | Budesonide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7445 | Budesonide | Budesonide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7445 | Budesonide | Budesonide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 52657 | ORIG | 2018-02-15 |