Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
CHEPLAPHARM Arzneimittel GmbH
329834878
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
F. Hoffmann-La Roche AG
H2-Pharma, LLC
CHEPLAPHARM Arzneimittel GmbH
482242971
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Valcyte
Product Details
NDC Product Code
61269-485Application Number
NDA022257Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
April 14, 2023SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
ValganciclovirActive
Code: 4P3T9QF9NZClass: ACTIRQuantity: 50 mg in 1 mL
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
ACACIAInactive
Code: 5C5403N26OClass: IACT
Valcyte
Product Details
NDC Product Code
61269-480Application Number
NDA021304Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
April 14, 2023MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
ValganciclovirActive
Code: 4P3T9QF9NZClass: ACTIRQuantity: 450 mg in 1 1
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT