Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Ajanta Pharma Limited
918594859
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Ajanta Pharma Ltd., Dahej
Ajanta Pharma USA Inc.
Ajanta Pharma Limited
862199968
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
27241-159Application Number
ANDA212890Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 10, 2022ValganciclovirActive
Code: 4P3T9QF9NZClass: ACTIRQuantity: 50 mg in 1 mL
TARTARIC ACIDInactive
Code: W4888I119HClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ACACIAInactive
Code: 5C5403N26OClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1Class: IACT
OCTENYLSUCCINIC ACIDInactive
Code: 12UZE4X73LClass: IACT