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Application 215809
- Type
- NDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ERMEZA | LEVOTHYROXINE SODIUM | SOLUTION;ORAL | 150MCG/5ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 49502-378 | ERMEZA | levothyroxine sodium | Mylan Specialty L.P. | NDA | Current |
| 49502-378 | ERMEZA | levothyroxine sodium | Mylan Specialty L.P. | NDA | Current |
| 49502-378 | ERMEZA | levothyroxine sodium | Mylan Specialty L.P. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72663 | ORIG | 2022-11-21 |
| 71978 | ORIG | 2022-08-31 |
| 70867 | ORIG | 2022-04-29 |