leucovorin calcium · Hospira · NDA 008107, 018459
Leucovorin Calcium
Earliest generic entry, as listed · earliest of 5 marketed strengths
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
- Generic approved · ANDA 218200, Gland · 008107-002Approved 12 Nov 2025Detected 25 Oct 2026Historical import
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 008107 · 001 · RLD · discontinued | solution, intramuscular, intravenous | EQ 3MG BASE/ML (EQ 3MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 008107 · 002 · RLD · discontinued | injectable, injection | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 008107 · 003 · RLD · discontinued | for solution, oral | EQ 60MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 008107 · 004 · RLD · discontinued | injectable, injection | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 008107 · 005 · RLD · discontinued | injectable, injection | EQ 350MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018459 · 001 · discontinued | tablet, oral | EQ 5MG BASE | open |