All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2026-P-0749
Requests that the FDA determine whether Leucovorin Calcium For Oral Solution, EQ 60 mg base/vial, (NDA 008107) held by Hospira Inc. has been voluntarily withdrawn or withheld from sale for reasons of safety or efficacy
Documents
5
Comments
0
Description
CLOSED
Key Dates
Comment Period OpensJan 26, 2026
Comment Period ClosesJul 23, 2026
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CDER
Citizen Petition
Apotex Inc.
determine whether Leucovorin Calcium
For Oral Solution, EQ 60 mg base/vial,
(NDA 008107) held by Hospira Inc. has been
voluntarily withdrawn or withheld from
sale for reasons of safety or efficacy
Data from Regulations.gov