Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Appco Pharma LLC
078510186
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Appco Pharma LLC
Florida Pharmaceutical Products, LLC
Appco Pharma LLC
078510186
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
71921-210Application Number
ANDA216317Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 20, 2023ValganciclovirActive
Code: GCU97FKN3RClass: ACTIBQuantity: 50 mg in 1 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
TARTARIC ACIDInactive
Code: W4888I119HClass: IACT