Application 204015
- Type
- ANDA
- Sponsor
- MYLAN LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | POWDER;INTRAVENOUS | EQ 115MG BASE/VIAL | No | No |
| 002 | FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | POWDER;INTRAVENOUS | EQ 150MG BASE/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67457-888 | fosaprepitant | fosaprepitant | Mylan Institutional LLC | ANDA | Current |
| 67457-888 | fosaprepitant | fosaprepitant | Mylan Institutional LLC | ANDA | Current |
| 67457-889 | fosaprepitant | fosaprepitant | Mylan Institutional LLC | ANDA | Current |
| 67457-889 | fosaprepitant | fosaprepitant | Mylan Institutional LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 60235 | ORIG | 2019-10-04 |