Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
MSN Pharmaceuticals Inc.
MAJOR PHARMACEUTICALS
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
0904-7419Application Number
ANDA210169Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 28, 2023FUMARIC ACIDInactive
Code: 88XHZ13131Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
ValganciclovirActive
Code: 4P3T9QF9NZClass: ACTIRQuantity: 50 mg in 1 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACT