Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Strides Pharma Global Pte. Ltd.
659220961
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Strides Pharma, Inc
Strides Pharma Science Limited
Strides Pharma Global Pte. Ltd.
118344504
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Valganciclovir
Product Details
NDC Product Code
64380-153Application Number
ANDA200790Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 26, 2024ValganciclovirActive
Code: 4P3T9QF9NZClass: ACTIRQuantity: 450 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT