MedPath
FDA Approval

Oxybutynin Chloride

January 21, 2010

HUMAN PRESCRIPTION DRUG LABEL

Oxybutynin(10 mg in 1 1)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products (2)

Oxybutynin Chloride

54868-5728

ANDA076644

ANDA (C73584)

ORAL

January 21, 2010

Code: L9F3D9RENQClass: ACTIBQuantity: 10 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WOClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT

Oxybutynin Chloride

54868-5742

ANDA076702

ANDA (C73584)

ORAL

January 21, 2010

Code: L9F3D9RENQClass: ACTIBQuantity: 5 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WOClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
© Copyright 2025. All Rights Reserved by MedPath