MedPath
FDA Approval

Escitalopram

January 5, 2024

HUMAN PRESCRIPTION DRUG LABEL

Escitalopram(10 mg in 1 1)

Manufacturing Establishments (2)

Intas Pharmaceuticals Limited.

Accord Healthcare Inc.

725927649

Intas Pharmaceuticals Limited

Accord Healthcare Inc.

915837971

Products (3)

Escitalopram

16729-169

ANDA202389

ANDA (C73584)

ORAL

January 5, 2024

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JCClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
Code: 5U85DBW7LOClass: ACTIMQuantity: 10 mg in 1 1

Escitalopram

16729-168

ANDA202389

ANDA (C73584)

ORAL

January 5, 2024

MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JCClass: IACT
Code: 5U85DBW7LOClass: ACTIMQuantity: 5 mg in 1 1

Escitalopram

16729-170

ANDA202389

ANDA (C73584)

ORAL

January 5, 2024

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JCClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: 5U85DBW7LOClass: ACTIMQuantity: 20 mg in 1 1
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
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