Fosdenopterin (Nulibry)
Reconstitution onlyFull monograph review pending
U.S. label preparation
Nulibry · Reconstitution only
- Preparation
- Use 5 mL sterile water for injection in each vial. The withdrawable solution contains 9.5 mg in 5 mL (1.9 mg/mL).
- Administration and handling
- Use the calculated dose volume and the administration method for that volume in section 2.4.
Product and source details
Sentynl Therapeutics, Inc. · NDA214018
Product NDC: 42358-295
SPL effective 2026-05-26 | SPL version 4. Checked 2026-11-13.
Source for this summary: U.S. prescribing information. Use the full label for dose selection, contraindications, preparation tables and monitoring.
Product identifiers and clinical review status
U.S. label preparation available. Full monograph review pending.
Exact formulation, concentration, container, manufacturer, regulatory identifiers, and a reproducible label snapshot have not all been reconciled.
What remains to be completed
- Obtain independent corroboration of the label preparation where available.
- Complete indication- and age-specific dosing, incompatibility, monitoring and stability review.
- Assess any proposed compounding BUD for the exact formulation, concentration, container and conditions.