Application 040333
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUOROURACIL | FLUOROURACIL | INJECTABLE;INJECTION | 500MG/10ML (50MG/ML) | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0703-3015 | Adrucil | Fluorouracil | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-3015 | Adrucil | Fluorouracil | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-3015 | Adrucil | Fluorouracil | Teva Parenteral Medicines, Inc. | ANDA | Current |