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FDA Approval

RIVASTIGMINE TARTRATE

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

FDA Approval Summary

Company

Ajanta Pharma Limited

DUNS: 918594859

Effective Date

February 19, 2018

Labeling Type

Human Prescription Drug Label

Active Ingredients

Rivastigmine(1.5 mg in 1 1)

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 Limited

DUNS Number

918594859

Products4

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

RIVASTIGMINE TARTRATE

Product Details

NDC Product Code

27241-090

Application Number

ANDA207797

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 19, 2018

Ingredients

RivastigmineActive

Code: 9IY2357JPEClass: ACTIMQuantity: 1.5 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

RIVASTIGMINE TARTRATE

Product Details

NDC Product Code

27241-092

Application Number

ANDA207797

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 19, 2018

Ingredients

RivastigmineActive

Code: 9IY2357JPEClass: ACTIMQuantity: 4.5 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

RIVASTIGMINE TARTRATE

Product Details

NDC Product Code

27241-093

Application Number

ANDA207797

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 19, 2018

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

RivastigmineActive

Code: 9IY2357JPEClass: ACTIMQuantity: 6 mg in 1 1

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

RIVASTIGMINE TARTRATE

Product Details

NDC Product Code

27241-091

Application Number

ANDA207797

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 19, 2018

Ingredients

RivastigmineActive

Code: 9IY2357JPEClass: ACTIMQuantity: 3 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

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