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FDA Approval

Oxybutynin Chloride

CompanyMarlex Pharmaceuticals Inc (DUNS: 782540215)

Effective Date

February 13, 2016

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Oxybutynin(15 mg in 1 1)

Products (3)

Oxybutynin Chloride

NDC Product Code

10135-611

Application Number

ANDA204010

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 12, 2019

Ingredients

OxybutyninActive

Code: L9F3D9RENQClass: ACTIBQuantity: 15 mg in 1 1

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8JClass: IACT

HYDROGENATED COTTONSEED OILInactive

Code: Z82Y2C65EAClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

Oxybutynin Chloride

NDC Product Code

10135-609

Application Number

ANDA204010

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 12, 2019

Ingredients

OxybutyninActive

Code: L9F3D9RENQClass: ACTIBQuantity: 5 mg in 1 1

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8JClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

HYDROGENATED COTTONSEED OILInactive

Code: Z82Y2C65EAClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

D&C RED NO. 27Inactive

Code: 2LRS185U6KClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

Oxybutynin Chloride

NDC Product Code

10135-610

Application Number

ANDA204010

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 12, 2019

Ingredients

OxybutyninActive

Code: L9F3D9RENQClass: ACTIBQuantity: 10 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

HYDROGENATED COTTONSEED OILInactive

Code: Z82Y2C65EAClass: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8JClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

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