Application 212548
- Type
- ANDA
- Sponsor
- XIROMED
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FOSFOMYCIN TROMETHAMINE | FOSFOMYCIN TROMETHAMINE | FOR SOLUTION;ORAL | EQ 3GM BASE/PACKET | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-5826 | FOSFOMYCIN TROMETHAMINE | Granules for Oral | A-S Medication Solutions | ANDA | Current |
| 70700-268 | FOSFOMYCIN TROMETHAMINE | Granules for Oral Solution | XIROMED LLC | ANDA | Current |
| 70700-268 | FOSFOMYCIN TROMETHAMINE | Granules for Oral Solution | XIROMED LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 65506 | ORIG | 2020-12-07 |