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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

Alembic Pharmaceuticals Inc.

DUNS: 079288842

Effective Date

March 21, 2022

Labeling Type

Human Prescription Drug Label

Active Ingredients

Rivastigmine(6 mg in 1 1)

Manufacturing Establishments1

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

Alembic Pharmaceuticals Limited

Labeler

Alembic Pharmaceuticals Inc.

DUNS Number

650574671

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

62332-066

Application Number

ANDA091689

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 7, 2022

Ingredients

RivastigmineActive

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

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

Rivastigmine Tartrate

Product Details

NDC Product Code

62332-065

Application Number

ANDA091689

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 7, 2022

Ingredients

RivastigmineActive

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

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

Rivastigmine Tartrate

Product Details

NDC Product Code

62332-063

Application Number

ANDA091689

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 7, 2022

Ingredients

RivastigmineActive

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

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

Rivastigmine Tartrate

Product Details

NDC Product Code

62332-064

Application Number

ANDA091689

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 7, 2022

Ingredients

RivastigmineActive

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

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

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

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