Registrants (1)
Zydus Pharmaceuticals USA Inc.
156861945
Manufacturing Establishments (1)
Zydus Lifesciences Limited
Zydus Pharmaceuticals USA Inc.
Zydus Pharmaceuticals USA Inc.
918596198
Products (3)
oxybutynin
68382-257
ANDA202332
ANDA (C73584)
ORAL
November 7, 2023
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
OxybutyninActive
Code: L9F3D9RENQClass: ACTIBQuantity: 15 mg in 1 1
ALGINIC ACIDInactive
Code: 8C3Z4148WZClass: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
oxybutynin
68382-255
ANDA202332
ANDA (C73584)
ORAL
November 7, 2023
OxybutyninActive
Code: L9F3D9RENQClass: ACTIBQuantity: 5 mg in 1 1
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
ALGINIC ACIDInactive
Code: 8C3Z4148WZClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
oxybutynin
68382-256
ANDA202332
ANDA (C73584)
ORAL
November 7, 2023
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
OxybutyninActive
Code: L9F3D9RENQClass: ACTIBQuantity: 10 mg in 1 1
ALGINIC ACIDInactive
Code: 8C3Z4148WZClass: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT