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FDA Approval

Escitalopram Oxalate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Amneal Pharmaceuticals LLC

DUNS: 123797875

Effective Date

November 8, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Escitalopram(5 mg in 1 1)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Escitalopram Oxalate

Product Details

NDC Product Code

65162-019

Application Number

ANDA205619

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 20, 2023

Ingredients

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

EscitalopramActive

Code: 5U85DBW7LOClass: ACTIMQuantity: 5 mg in 1 1

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

Escitalopram Oxalate

Product Details

NDC Product Code

65162-021

Application Number

ANDA205619

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 20, 2023

Ingredients

EscitalopramActive

Code: 5U85DBW7LOClass: ACTIMQuantity: 20 mg in 1 1

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Escitalopram Oxalate

Product Details

NDC Product Code

65162-020

Application Number

ANDA205619

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 20, 2023

Ingredients

EscitalopramActive

Code: 5U85DBW7LOClass: ACTIMQuantity: 10 mg in 1 1

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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