MedPath
FDA Approval

oxybutynin

November 7, 2023

HUMAN PRESCRIPTION DRUG LABEL

Oxybutynin(15 mg in 1 1)

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
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

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
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
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