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FDA Approval

Escitalopram

CompanyPD-Rx Pharmaceuticals, Inc. (DUNS: 156893695)

Effective Date

September 26, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Escitalopram(20 mg in 1 1)

Registrants (1)

PD-Rx Pharmaceuticals, Inc.

DUNS Number

156893695

Manufacturing Establishments (1)

PD-Rx Pharmaceuticals, Inc.

Labeler

PD-Rx Pharmaceuticals, Inc.

Registrant

PD-Rx Pharmaceuticals, Inc.

DUNS Number

156893695

Products (1)

Escitalopram

NDC Product Code

43063-661

Application Number

ANDA202389

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 26, 2023

Ingredients

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

HYPROMELLOSE 2910 (15000 MPA.S)Inactive

Code: 288VBX44JCClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

EscitalopramActive

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

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