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Application 203609
- Type
- ANDA
- Sponsor
- SAGENT PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUOROURACIL | FLUOROURACIL | INJECTABLE;INJECTION | 2.5GM/50ML (50MG/ML) | No | No |
| 002 | FLUOROURACIL | FLUOROURACIL | INJECTABLE;INJECTION | 5GM/100ML (50MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 25021-215 | fluorouracil | fluorouracil | Sagent Pharmaceuticals | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85249 | SUPPL | 2026-03-03 |
| 85232 | SUPPL | 2026-03-03 |
| 77988 | SUPPL | 2024-03-27 |
| 77973 | SUPPL | 2024-03-26 |