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FDA Drug information

Esomeprazole Magnesium

Read time: 1 mins
Marketing start date: 27 Dec 2024
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Summary of product characteristics


Effective Time

20230619

Version

1

Spl Product Data Elements

Esomeprazole Magnesium Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM DIHYDRATE ESOMEPRAZOLE ANHYDROUS CITRIC ACID CROSPOVIDONE DEXTROSE FERRIC OXIDE RED GLYCERYL MONOSTEARATE HYDROXYPROPYL CELLULOSE (90000 WAMW) MAGNESIUM STEARATE MANNITOL METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYSORBATE 80 POVIDONE STRAWBERRY SUCROSE TALC TRIETHYL CITRATE XANTHAN GUM WHITE TO PALE BROWN PALE RED TO RED Esomeprazole Magnesium Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM DIHYDRATE ESOMEPRAZOLE ANHYDROUS CITRIC ACID CROSPOVIDONE DEXTROSE FERRIC OXIDE RED GLYCERYL MONOSTEARATE HYDROXYPROPYL CELLULOSE (TYPE E) MAGNESIUM STEARATE MANNITOL METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A POLYSORBATE 80 POVIDONE STRAWBERRY SUCROSE TALC TRIETHYL CITRATE XANTHAN GUM WHITE TO PALE BROWN PALE RED TO RED

Application Number

ANDA206055

Brand Name

Esomeprazole Magnesium

Generic Name

Esomeprazole Magnesium

Product Ndc

70771-1391

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1391-1 20 mg packet Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1391-3 unit dose packages of 30: 20 mg packets Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1392-1 40 mg packet Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1392-3 unit dose packages of 30: 40 mg packets Rx Only 20 mg packet 20 mg carton 40 mg packet 40 mg carton

Drug section

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