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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

Chartwell RX, LLC

DUNS: 079394054

Effective Date

October 6, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Rivastigmine(3 mg in 1 1)

Manufacturing Establishments1

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

Chartwell Pharmaceuticals Congers, LLC

Labeler

Chartwell RX, LLC

DUNS Number

118673447

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

62135-901

Application Number

ANDA207797

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 6, 2023

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

GELATINInactive

Code: 2G86QN327LClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

Rivastigmine Tartrate

Product Details

NDC Product Code

62135-900

Application Number

ANDA207797

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 6, 2023

Ingredients

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

RivastigmineActive

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

Rivastigmine Tartrate

Product Details

NDC Product Code

62135-902

Application Number

ANDA207797

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 6, 2023

Ingredients

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

RivastigmineActive

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

Rivastigmine Tartrate

Product Details

NDC Product Code

62135-903

Application Number

ANDA207797

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 6, 2023

Ingredients

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

RivastigmineActive

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

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