Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
MSN Pharmaceuticals Inc.
Novadoz Pharmaceuticals LLC
079229051
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
valganciclovir hydrochloride
Product Details
NDC Product Code
72205-019Application Number
ANDA210169Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 14, 2022POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
ValganciclovirActive
Code: 4P3T9QF9NZClass: ACTIRQuantity: 50 mg in 1 mL
FUMARIC ACIDInactive
Code: 88XHZ13131Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT