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FDA Approval

oxybutynin chloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Chartwell RX, LLC

DUNS: 079394054

Effective Date

March 6, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Oxybutynin(10 mg in 1 1)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

oxybutynin chloride

Product Details

NDC Product Code

62135-508

Application Number

ANDA078503

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 6, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6Class: IACT

ANHYDROUS DEXTROSEInactive

Code: 5SL0G7R0OKClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

TARTARIC ACIDInactive

Code: W4888I119HClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

OxybutyninActive

Code: L9F3D9RENQClass: ACTIBQuantity: 10 mg in 1 1

oxybutynin chloride

Product Details

NDC Product Code

62135-509

Application Number

ANDA078503

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 6, 2023

Ingredients

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

ANHYDROUS DEXTROSEInactive

Code: 5SL0G7R0OKClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TARTARIC ACIDInactive

Code: W4888I119HClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

OxybutyninActive

Code: L9F3D9RENQClass: ACTIBQuantity: 15 mg in 1 1

oxybutynin chloride

Product Details

NDC Product Code

62135-507

Application Number

ANDA078503

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 6, 2023

Ingredients

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6Class: IACT

ANHYDROUS DEXTROSEInactive

Code: 5SL0G7R0OKClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

TARTARIC ACIDInactive

Code: W4888I119HClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

OxybutyninActive

Code: L9F3D9RENQClass: ACTIBQuantity: 5 mg in 1 1

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

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