Application 209219
- Type
- ANDA
- Sponsor
- INGENUS PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUOROURACIL | FLUOROURACIL | INJECTABLE;INJECTION | 500MG/10ML (50MG/ML) | No | No |
| 002 | FLUOROURACIL | FLUOROURACIL | INJECTABLE;INJECTION | 1GM/20ML (50MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50742-423 | FLUOROURACIL | FLUOROURACIL | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-423 | FLUOROURACIL | FLUOROURACIL | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-423 | FLUOROURACIL | FLUOROURACIL | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-481 | FLUOROURACIL | FLUOROURACIL | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-481 | FLUOROURACIL | FLUOROURACIL | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-481 | FLUOROURACIL | FLUOROURACIL | Ingenus Pharmaceuticals, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85250 | SUPPL | 2026-03-03 |
| 85233 | SUPPL | 2026-03-03 |
| 77987 | SUPPL | 2024-03-27 |
| 77974 | SUPPL | 2024-03-26 |