Application 078639
- Type
- ANDA
- Sponsor
- MYLAN INSTITUTIONAL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FOMEPIZOLE | FOMEPIZOLE | INJECTABLE;INJECTION | 1.5GM/1.5ML (1GM/ML) | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67457-211 | Fomepizole | Fomepizole | Mylan Institutional LLC | ANDA | Current |
| 67457-211 | Fomepizole | Fomepizole | Mylan Institutional LLC | ANDA | Current |
| 67457-211 | Fomepizole | Fomepizole | Mylan Institutional LLC | ANDA | Current |