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FDA Approval

Risedronate Sodium

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

FDA Approval Summary

Company

Macleods Pharmaceuticals Limited

DUNS: 862128535

Effective Date

August 1, 2023

Labeling Type

Human Prescription Drug Label

Active Ingredients

Risedronic acid(30 mg in 1 1)

Manufacturing Establishments1

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

Macleods Pharmaceuticals Limited

Labeler

Macleods Pharmaceuticals Limited

DUNS Number

676369519

Products3

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

Risedronate Sodium

Product Details

NDC Product Code

33342-108

Application Number

ANDA203533

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 1, 2023

Ingredients

Risedronic acidActive

Code: OFG5EXG60LClass: ACTIBQuantity: 30 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

Risedronate Sodium

Product Details

NDC Product Code

33342-107

Application Number

ANDA203533

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 1, 2023

Ingredients

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

Risedronic acidActive

Code: OFG5EXG60LClass: ACTIBQuantity: 5 mg in 1 1

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

Risedronate Sodium

Product Details

NDC Product Code

33342-109

Application Number

ANDA203533

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 1, 2023

Ingredients

Risedronic acidActive

Code: OFG5EXG60LClass: ACTIBQuantity: 35 mg in 1 1

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

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