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Application 210124
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
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 |
|---|
| 68001-525 | Fluorouracil | Fluorouracil | BluePoint Laboratories | ANDA | Current |
| 68083-292 | Fluorouracil | Fluorouracil | Gland Pharma Limited | ANDA | Current |
| 68083-292 | Fluorouracil | Fluorouracil | Gland Pharma Limited | ANDA | Current |
| 68083-293 | Fluorouracil | Fluorouracil | Gland Pharma Limited | ANDA | Current |
| 68083-293 | Fluorouracil | Fluorouracil | Gland Pharma Limited | ANDA | Current |
| 70700-188 | Fluorouracil | Fluorouracil | Xiromed LLC | ANDA | Current |
| 70700-189 | Fluorouracil | Fluorouracil | Xiromed LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85254 | SUPPL | 2026-03-03 |
| 85236 | SUPPL | 2026-03-03 |
| 77984 | SUPPL | 2024-03-27 |
| 77977 | SUPPL | 2024-03-26 |