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FDA Approval

Escitalopram

CompanyProficient Rx LP (DUNS: 079196022)

Effective Date

May 2, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Escitalopram(10 mg in 1 1)

Manufacturing Establishments (1)

Proficient Rx LP

Labeler

Proficient Rx LP

DUNS Number

079196022

Products (1)

Escitalopram

NDC Product Code

71205-344

Application Number

ANDA202389

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 2, 2022

Ingredients

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

EscitalopramActive

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

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

HYPROMELLOSE 2910 (15000 MPA.S)Inactive

Code: 288VBX44JCClass: IACT

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