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- Irbesartan IRBESARTAN 150 mg/1 Zydus Lifesciences Limited
Irbesartan
- Irbesartan IRBESARTAN 150 mg/1 Proficient Rx LP
- Irbesartan IRBESARTAN 150 mg/1 Unichem Pharmaceuticals (USA), Inc.
- Irbesartan IRBESARTAN 150 mg/1 Zydus Pharmaceuticals USA Inc.
- Irbesartan IRBESARTAN 150 mg/1 Proficient Rx LP
- Irbesartan IRBESARTAN 150 mg/1 AvPAK
- Irbesartan IRBESARTAN 150 mg/1 REMEDYREPACK INC.
- Irbesartan IRBESARTAN 150 mg/1 Camber Pharmaceuticals, Inc.
- Irbesartan IRBESARTAN 150 mg/1 Macleods Pharmaceuticals Limited
- Irbesartan IRBESARTAN 150 mg/1 Lupin Pharmaceuticals, Inc.
- IRBESARTAN IRBESARTAN 150 mg/1 REMEDYREPACK INC.
- IRBESARTAN IRBESARTAN 150 mg/1 Jubilant Cadista Pharmaceuticals Inc.
- IRBESARTAN IRBESARTAN 150 mg/1 Jubilant Cadista Pharmaceuticals Inc.
- Irbesartan IRBESARTAN 150 mg/1 A-S Medication Solutions
- Irbesartan IRBESARTAN 150 mg/1 Lupin Pharmaceuticals, Inc.
- Irbesartan and Hydrochlorothiazide HYDROCHLOROTHIAZIDE 12.5 mg/1 Bryant Ranch Prepack
- IRBESARTAN IRBESARTAN 150 mg/1 Alembic Pharmaceuticals Limited
- Irbesartan IRBESARTAN 150 mg/1 Camber Pharmaceuticals, Inc.
- Irbesartan and Hydrochlorothiazide HYDROCHLOROTHIAZIDE 12.5 mg/1 Proficient Rx LP
- Irbesartan IRBESARTAN 150 mg/1 Solco Healthcare U.S., LLC
- Irbesartan and Hydrochlorothiazide HYDROCHLOROTHIAZIDE 12.5 mg/1 REMEDYREPACK INC.
- Irbesartan IRBESARTAN 150 mg/1 ScieGen Pharmaceuticals, Inc.
- Irbesartan IRBESARTAN 150 mg/1 Proficient Rx LP
- Irbesartan IRBESARTAN 150 mg/1 REMEDYREPACK INC.
- Irbesartan IRBESARTAN 150 mg/1 REMEDYREPACK INC.
- Irbesartan and Hydrochlorothiazide HYDROCHLOROTHIAZIDE 12.5 mg/1 Bryant Ranch Prepack
- Irbesartan and Hydrochlorothiazide HYDROCHLOROTHIAZIDE 12.5 mg/1 Solco Healthcare US, LLC
- Irbesartan and Hydrochlorothiazide HYDROCHLOROTHIAZIDE 12.5 mg/1 Alembic Pharmaceuticals Inc.
- IRBESARTAN IRBESARTAN 150 mg/1 Alembic Pharmaceuticals Inc.
- Irbesartan IRBESARTAN 150 mg/1 Proficient Rx LP
- Irbesartan IRBESARTAN 150 mg/1 Aurobindo Pharma Limited
- Irbesartan IRBESARTAN 150 mg/1 Zydus Lifesciences Limited
- Irbesartan and Hydrochlorothiazide HYDROCHLOROTHIAZIDE 12.5 mg/1 Alembic Pharmaceuticals Limited
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
70771-1160
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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