Registrants (1)
Preferred Pharmaceuticals, Inc.
791119022
Manufacturing Establishments (1)
Preferred Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc.
791119022
Products (1)
Valacyclovir
68788-7587
ANDA203047
ANDA (C73584)
ORAL
October 9, 2023
ValaciclovirActive
Code: G447S0T1VCClass: ACTIRQuantity: 1 g in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT