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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

20230926

Version

8

Spl Product Data Elements

lansoprazole lansoprazole LANSOPRAZOLE LANSOPRAZOLE ALCOHOL AMMONIA BUTYL ALCOHOL D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES ISOPROPYL ALCOHOL SHELLAC MAGNESIUM CARBONATE METHACRYLIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 PROPYLENE GLYCOL WATER GELATIN SUCROSE TALC TITANIUM DIOXIDE POTASSIUM HYDROXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED STARCH, CORN PINK WHITE CAPSULE ZA;50;15mg lansoprazole lansoprazole LANSOPRAZOLE LANSOPRAZOLE ALCOHOL AMMONIA BUTYL ALCOHOL D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES ISOPROPYL ALCOHOL SHELLAC MAGNESIUM CARBONATE METHACRYLIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 PROPYLENE GLYCOL WATER GELATIN SUCROSE TALC TITANIUM DIOXIDE POTASSIUM HYDROXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED STARCH, CORN PINK WHITE CAPSULE ZA;51;30mg

Application Number

ANDA202366

Brand Name

Lansoprazole

Generic Name

lansoprazole

Product Ndc

65841-769

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

NDC 65841-769-10 in bottle of 1000 Capsules Lansoprazole Delayed-release Capsules USP, 15 mg Rx only 1000 Capsules NDC 65841-770-10 in bottle of 1000 Capsules Lansoprazole Delayed-release Capsules USP, 30 mg Rx only 1000 Capsules Structured formula for lansoprazole Structured formula for lansoprazole

Spl Medguide

Manufactured by: Cadila Healthcare Ltd. India.

Drug section

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