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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

Sun Pharmaceutical Industries, Inc.

DUNS: 146974886

Effective Date

January 31, 2019

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.

Sun Pharmaceutical Industries Limited

Labeler

Sun Pharmaceutical Industries, Inc.

DUNS Number

725959238

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

62756-148

Application Number

ANDA077131

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 31, 2019

Ingredients

RivastigmineActive

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

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Rivastigmine Tartrate

Product Details

NDC Product Code

62756-145

Application Number

ANDA077131

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 31, 2019

Ingredients

RivastigmineActive

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

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Rivastigmine Tartrate

Product Details

NDC Product Code

62756-146

Application Number

ANDA077131

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 31, 2019

Ingredients

RivastigmineActive

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

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Rivastigmine Tartrate

Product Details

NDC Product Code

62756-147

Application Number

ANDA077131

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 31, 2019

Ingredients

RivastigmineActive

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

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

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