Application 064117
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MITOMYCIN | MITOMYCIN | INJECTABLE;INJECTION | 5MG/VIAL | No | No |
| 002 | MITOMYCIN | MITOMYCIN | INJECTABLE;INJECTION | 20MG/VIAL | No | No |
| 003 | MITOMYCIN | MITOMYCIN | INJECTABLE;INJECTION | 40MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0143-9135 | Mitomycin | Mitomycin | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9136 | Mitomycin | Mitomycin | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9279 | Mitomycin | Mitomycin | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9280 | Mitomycin | Mitomycin | West-Ward Pharmaceuticals Corp | ANDA | Current |