Registrants (1)
Zydus Lifesciences Limited
918596198
Manufacturing Establishments (1)
Zydus Lifesciences Limited
Zydus Lifesciences Limited
Zydus Lifesciences Limited
918596198
Products (2)
Valacyclovir
65841-630
ANDA079137
ANDA (C73584)
ORAL
November 5, 2022
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ValaciclovirActive
Code: G447S0T1VCClass: ACTIRQuantity: 1000 mg in 1 1
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
Valacyclovir
65841-629
ANDA079137
ANDA (C73584)
ORAL
November 5, 2022
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
ValaciclovirActive
Code: G447S0T1VCClass: ACTIRQuantity: 500 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT