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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

20230921

Version

4

Spl Product Data Elements

esomeprazole magnesium esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM DIHYDRATE ESOMEPRAZOLE ALCOHOL AMMONIA BUTYL ALCOHOL FD&C BLUE NO. 1 FD&C RED NO. 3 FERROSOFERRIC OXIDE GELATIN GLYCERYL CAPRYLOCAPRATE HYDROXYPROPYL CELLULOSE (90000 WAMW) ISOPROPYL ALCOHOL MAGNESIUM OXIDE MAGNESIUM STEARATE MANNITOL METHACRYLIC ACID POLYSORBATE 80 POTASSIUM HYDROXIDE POVIDONE K30 PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER DARK BLUE OPAQUE (CAP) WHITE OPAQUE (BODY) CAPSULE 441;20mg esomeprazole magnesium esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM DIHYDRATE ESOMEPRAZOLE ALCOHOL AMMONIA BUTYL ALCOHOL D&C RED NO. 28 FD&C BLUE NO. 1 FERROSOFERRIC OXIDE GELATIN GLYCERYL CAPRYLOCAPRATE HYDROXYPROPYL CELLULOSE (90000 WAMW) ISOPROPYL ALCOHOL MAGNESIUM OXIDE MAGNESIUM STEARATE MANNITOL METHACRYLIC ACID POLYSORBATE 80 POTASSIUM HYDROXIDE POVIDONE K30 PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER BLUE OPAQUE (CAP) OPAQUE WHITE (BODY) CAPSULE 442;40mg

Application Number

ANDA206296

Brand Name

Esomeprazole magnesium

Generic Name

esomeprazole magnesium

Product Ndc

70771-1494

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1493-3 Esomeprazole Magnesium Delayed-release Capsules, USP 20 mg 30 Capsules NDC 70771-1494-3 Esomeprazole Magnesium Delayed-release Capsules, USP 40 mg 30 Capsules 20 mg 30s label 40 mg 30s label

Spl Medguide

SPL MEDGUIDE

Drug section

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