Manufacturing Establishments6
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Cambrex Agawam MA
Fennec Pharmaceuticals Inc.
079509111
SGS Life Science Services
Fennec Pharmaceuticals Inc.
049859261
Cambrex Durham, NC
Fennec Pharmaceuticals Inc.
108353231
Cambrex Charles City, Inc.
Fennec Pharmaceuticals Inc.
782974257
Berkshire Sterile Manufacturing
Fennec Pharmaceuticals Inc.
079589218
A+ Secure Packaging LLC, d/b/a Cardinal Health Packaging
Fennec Pharmaceuticals Inc.
963589036
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PEDMARK
Product Details
NDC Product Code
73077-010Application Number
NDA212937Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
September 30, 2022BORIC ACIDInactive
Code: R57ZHV85D4Class: IACT
Sodium ThiosulfateActive
Code: HX1032V43MClass: ACTIMQuantity: 12.5 g in 100 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT