Application 205457
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-2510 | Budesonide | Budesonide | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2510 | Budesonide | Budesonide | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2510 | Budesonide | Budesonide | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2510 | Budesonide | Budesonide | Actavis Pharma, Inc. | ANDA | Current |
| 51407-224 | Budesonide | Budesonide | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-224 | Budesonide | Budesonide | Golden State Medical Supply | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 55232 | ORIG | 2018-08-20 |