Application 201688
- Type
- NDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TOBI PODHALER | TOBRAMYCIN | POWDER;INHALATION | 28MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0078-0630 | TOBI Podhaler | Tobramycin | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0630 | TOBI Podhaler | Tobramycin | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0630 | TOBI Podhaler | Tobramycin | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0630 | TOBI Podhaler | Tobramycin | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0630 | TOBI Podhaler | Tobramycin | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0630 | TOBI Podhaler | Tobramycin | Novartis Pharmaceuticals Corporation | NDA | Current |
| 49502-346 | TOBI Podhaler | Tobramycin | Mylan Specialty L.P. | NDA | Current |
| 49502-346 | TOBI Podhaler | Tobramycin | Mylan Specialty L.P. | NDA | Current |
| 49502-346 | TOBI Podhaler | Tobramycin | Mylan Specialty L.P. | NDA | Current |
| 49502-346 | TOBI Podhaler | Tobramycin | Mylan Specialty L.P. | NDA | Current |
| 49502-346 | TOBI Podhaler | Tobramycin | Mylan Specialty L.P. | NDA | Current |
| 49502-346 | TOBI Podhaler | Tobramycin | Mylan Specialty L.P. | NDA | Current |
| 49502-346 | TOBI Podhaler | Tobramycin | Mylan Specialty L.P. | NDA | Current |
| 49502-346 | TOBI Podhaler | Tobramycin | Mylan Specialty L.P. | NDA | Current |
| 49502-346 | TOBI Podhaler | Tobramycin | Mylan Specialty L.P. | NDA | Current |
| 49502-401 | TOBI Podhaler | Tobramycin | Mylan Specialty L.P. | NDA | Current |
| 49502-401 | TOBI Podhaler | Tobramycin | Mylan Specialty L.P. | NDA | Current |
| 49502-401 | TOBI Podhaler | Tobramycin | Mylan Specialty L.P. | NDA | Current |
| 49502-401 | TOBI Podhaler | Tobramycin | Mylan Specialty L.P. | NDA | Current |