All regulations
Nonrulemaking
FDA
FDA-2026-N-0707
GlaxoSmithKline; Withdrawal of Approval of a New Drug Application for Wellcovorin (leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg base
Documents
1
Comments
0
Key Dates
Comment Period OpensApr 10, 2026
Documents
| Type | Title | Status |
|---|---|---|
Notice |
Keywords
2025-604
CDER
GlaxoSmithKline
Withdrawal of
Approval of a New Drug Application for
Wellcovorin leucovorin calcium tablets
EQ 5 mg base and EQ 25 mg base
OPEN
Data from Regulations.gov