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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 of New York LLC

DUNS: 123797875

Effective Date

March 16, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Escitalopram(5 mg in 1 1)

Manufacturing Establishments1

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

Amneal Pharmaceuticals of New York, LLC

Labeler

Amneal Pharmaceuticals of New York LLC

DUNS Number

123797875

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

53746-019

Application Number

ANDA205619

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 16, 2023

Ingredients

EscitalopramActive

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

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Escitalopram Oxalate

Product Details

NDC Product Code

53746-021

Application Number

ANDA205619

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 16, 2023

Ingredients

EscitalopramActive

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

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Escitalopram Oxalate

Product Details

NDC Product Code

53746-020

Application Number

ANDA205619

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 16, 2023

Ingredients

EscitalopramActive

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

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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