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FDA Drug information

LANSOPRAZOLE

Read time: 1 mins
Marketing start date: 23 Nov 2024
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Summary of product characteristics


Effective Time

20230927

Version

5

Spl Product Data Elements

LANSOPRAZOLE LANSOPRAZOLE LANSOPRAZOLE LANSOPRAZOLE ANHYDROUS CITRIC ACID ASPARTAME CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE (15 MPA.S AT 5%) FERRIC OXIDE RED GLYCERYL MONOSTEARATE HYDROCHLORIC ACID HYPROMELLOSES MAGNESIUM CARBONATE MAGNESIUM STEARATE MANNITOL METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYACRYLIC ACID (250000 MW) POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 SILICON DIOXIDE SODIUM HYDROXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STRAWBERRY TALC TRIETHYL CITRATE XANTHAN GUM WHITE TO OFF-WHITE STRAWBERRY ROUND 771 LANSOPRAZOLE LANSOPRAZOLE LANSOPRAZOLE LANSOPRAZOLE ANHYDROUS CITRIC ACID ASPARTAME CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE (15 MPA.S AT 5%) FERRIC OXIDE RED GLYCERYL MONOSTEARATE HYDROCHLORIC ACID HYPROMELLOSES MAGNESIUM CARBONATE MAGNESIUM STEARATE MANNITOL METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYACRYLIC ACID (250000 MW) POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 SILICON DIOXIDE SODIUM HYDROXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STRAWBERRY TALC TRIETHYL CITRATE XANTHAN GUM WHITE TO OFF-WHITE STRAWBERRY ROUND 772

Application Number

ANDA200816

Brand Name

LANSOPRAZOLE

Generic Name

LANSOPRAZOLE

Product Ndc

70771-1133

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1132-4 Lansoprazole Delayed-release Orally Disintegrating Tablets, 15 mg R x only 100 Tablets (10 x 10 Unit Dose) NDC 70771-1133-4 Lansoprazole Delayed-release Orally Disintegrating Tablets, 30 mg R x only 100 Tablets (10 x 10 Unit Dose) Lansoprazole delayed-release orally disintegrating tablets, 15 mg Lansoprazole delayed-release orally disintegrating tablets, 30 mg

Spl Medguide

SPL MEDGUIDE

Drug section

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