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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

Ajanta Pharma USA Inc.

DUNS: 557554156

Effective Date

May 25, 2023

Labeling Type

Human Prescription Drug Label

Active Ingredients

Oxybutynin(10 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Ajanta Pharma Limited

DUNS Number

918594859

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Ajanta Pharma Limited

Labeler

Ajanta Pharma USA Inc.

Registrant

Ajanta Pharma Limited

DUNS Number

918594859

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

27241-156

Application Number

ANDA211655

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 25, 2023

Ingredients

HYPROMELLOSE 2208 (100 MPA.S)Inactive

Code: B1QE5P712KClass: IACT

OxybutyninActive

Code: L9F3D9RENQClass: ACTIBQuantity: 10 mg in 1 1

CALCIUM PHOSPHATE, UNSPECIFIED FORMInactive

Code: 97Z1WI3NDXClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

METHACRYLIC ACIDInactive

Code: 1CS02G8656Class: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

Oxybutynin Chloride

Product Details

NDC Product Code

27241-155

Application Number

ANDA211655

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 25, 2023

Ingredients

HYPROMELLOSE 2208 (100 MPA.S)Inactive

Code: B1QE5P712KClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

OxybutyninActive

Code: L9F3D9RENQClass: ACTIBQuantity: 5 mg in 1 1

METHACRYLIC ACIDInactive

Code: 1CS02G8656Class: IACT

CALCIUM PHOSPHATE, UNSPECIFIED FORMInactive

Code: 97Z1WI3NDXClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

Oxybutynin Chloride

Product Details

NDC Product Code

27241-157

Application Number

ANDA211655

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 25, 2023

Ingredients

OxybutyninActive

Code: L9F3D9RENQClass: ACTIBQuantity: 15 mg in 1 1

CALCIUM PHOSPHATE, UNSPECIFIED FORMInactive

Code: 97Z1WI3NDXClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

HYPROMELLOSE 2208 (100 MPA.S)Inactive

Code: B1QE5P712KClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

METHACRYLIC ACIDInactive

Code: 1CS02G8656Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

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