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FDA Approval

Rivastigmine Tartrate

CompanyAlembic Pharmaceuticals Limited (DUNS: 650574663)

Effective Date

January 16, 2023

Labeling Type

Human Prescription Drug Label

Active Ingredients

Rivastigmine(6 mg in 1 1)

Manufacturing Establishments (1)

Alembic Pharmaceuticals Limited

Labeler

Alembic Pharmaceuticals Limited

DUNS Number

650574671

Products (4)

Rivastigmine Tartrate

NDC Product Code

46708-066

Application Number

ANDA091689

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 16, 2023

Ingredients

RivastigmineActive

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

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

Rivastigmine Tartrate

NDC Product Code

46708-064

Application Number

ANDA091689

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 16, 2023

Ingredients

RivastigmineActive

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

Rivastigmine Tartrate

NDC Product Code

46708-063

Application Number

ANDA091689

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 16, 2023

Ingredients

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

RivastigmineActive

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

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

Rivastigmine Tartrate

NDC Product Code

46708-065

Application Number

ANDA091689

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 16, 2023

Ingredients

RivastigmineActive

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

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

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