Registrants (1)
Zydus Pharmaceuticals USA Inc.
156861945
Manufacturing Establishments (1)
Zydus Lifesciences Limited
Zydus Pharmaceuticals USA Inc.
Zydus Pharmaceuticals USA Inc.
863362789
Products (2)
CLOBAZAM
70710-1325
ANDA211449
ANDA (C73584)
ORAL
November 8, 2022
ClobazamActive
Code: 2MRO291B4UClass: ACTIBQuantity: 10 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CLOBAZAM
70710-1326
ANDA211449
ANDA (C73584)
ORAL
November 8, 2022
ClobazamActive
Code: 2MRO291B4UClass: ACTIBQuantity: 20 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT