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FDA Drug information

Irbesartan

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


Effective Time

20221013

Version

5

Spl Product Data Elements

Irbesartan Irbesartan IRBESARTAN IRBESARTAN CALCIUM STEARATE CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE STARCH, CORN POLOXAMER 188 WHITE TO OFF-WHITE CAPSULE ZE53 Irbesartan Irbesartan IRBESARTAN IRBESARTAN CALCIUM STEARATE CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE POLOXAMER 188 STARCH, CORN WHITE TO OFF-WHITE CAPSULE ZE54 Irbesartan Irbesartan IRBESARTAN IRBESARTAN CALCIUM STEARATE CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE POLOXAMER 188 STARCH, CORN WHITE TO OFF-WHITE CAPSULE ZE55

Application Number

ANDA079213

Brand Name

Irbesartan

Generic Name

Irbesartan

Product Ndc

70771-1161

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1159-0 in bottles of 1000 tablets Irbesartan Tablets USP, 75 mg 1000 Tablets Rx Only NDC 70771-1160-0 in bottles of 1000 tablets Irbesartan Tablets USP, 150 mg 1000 Tablets Rx Only NDC 70771-1161-0 in bottles of 1000 tablets Irbesartan Tablets USP, 300 mg 1000 Tablets Rx Only Irbesartan Tablets, USP - 75 mg Irbsertan Tablets USP, 150 mg Irbesartan Tablets USP, 300 mg

Drug section

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