fludarabine phosphate · Caplin One Labs · NDA 022137
Fludarabine Phosphate
Earliest generic entry, as listed
Open now
No marketed reference-listed strength; date taken from all listed strengths.
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 25 Oct 2026Generic approved · 022137-00123 Jul 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022137 · 001 · RLD · discontinued | injectable, injection | 50MG/2ML (25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |