Registrants (1)
Zydus Lifesciences Limited
918596198
Manufacturing Establishments (1)
Zydus Lifesciences Limited
Zydus Lifesciences Limited
Zydus Lifesciences Limited
918596198
Products (1)
divalproex sodium
65841-639
ANDA078919
ANDA (C73584)
ORAL
September 21, 2023
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
Divalproex sodiumActive
Code: 644VL95AO6Class: ACTIMQuantity: 125 mg in 1 1
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT