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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

Breckenridge Pharmaceutical, Inc

DUNS: 150554335

Effective Date

April 27, 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

Breckenridge Pharmaceutical, 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

51991-796

Application Number

ANDA091689

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 28, 2022

Ingredients

RivastigmineActive

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

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Rivastigmine Tartrate

Product Details

NDC Product Code

51991-794

Application Number

ANDA091689

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 28, 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

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

Rivastigmine Tartrate

Product Details

NDC Product Code

51991-793

Application Number

ANDA091689

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 28, 2022

Ingredients

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

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

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

Rivastigmine Tartrate

Product Details

NDC Product Code

51991-795

Application Number

ANDA091689

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 28, 2022

Ingredients

RivastigmineActive

Code: 9IY2357JPEClass: ACTIMQuantity: 4.5 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 REDInactive

Code: 1K09F3G675Class: IACT

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