Nulibry
These highlights do not include all the information needed to use NULIBRY safely and effectively. See full prescribing information for NULIBRY. NULIBRY (fosdenopterin) for injection, for intravenous useInitial U.S. Approval: 2021
Approved
Approval ID
736aeea3-f206-454d-95d0-fd30964e8aab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 28, 2022
Manufacturers
FDA
Sentynl Therapeutics, Inc.
DUNS: 078313706
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fosdenopterin hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42358-295
Application NumberNDA214018
Product Classification
M
Marketing Category
C73594
G
Generic Name
fosdenopterin hydrobromide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 28, 2022
FDA Product Classification
INGREDIENTS (6)
mannitolInactive
Quantity: 187.5 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
fosdenopterin hydrobromideActive
Quantity: 9.5 mg in 1 1
Code: X41B5W735T
Classification: ACTIM
sucroseInactive
Quantity: 62.5 mg in 1 1
Code: C151H8M554
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
ascorbic acidInactive
Quantity: 10 mg in 1 1
Code: PQ6CK8PD0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT