Application 020696
- Type
- NDA
- Sponsor
- PAR PHARM INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ANTIZOL | FOMEPIZOLE | INJECTABLE;INJECTION | 1.5GM/1.5ML (1GM/ML) | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 46129-200 | Antizol | fomepizole | PALADIN LABORATORIES (USA) INC | NDA | Current |