MedPath
FDA Approval

Oxybutynin Chloride

February 7, 2023

HUMAN PRESCRIPTION DRUG LABEL

Oxybutynin(10 mg in 1 1)

Manufacturing Establishments (1)

American Health Packaging

American Health Packaging

929561009

Products (2)

Oxybutynin Chloride Extended Release

68084-610

ANDA078503

ANDA (C73584)

ORAL

February 7, 2023

FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6Class: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OKClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TARTARIC ACIDInactive
Code: W4888I119HClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: L9F3D9RENQClass: ACTIBQuantity: 10 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT

Oxybutynin Chloride Extended Release

68084-480

ANDA078503

ANDA (C73584)

ORAL

February 7, 2023

FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OKClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TARTARIC ACIDInactive
Code: W4888I119HClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
Code: L9F3D9RENQClass: ACTIBQuantity: 5 mg in 1 1
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