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Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091370

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NDA 091370 describes IRBESARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Atlas Pharms Llc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hisun Pharm Hangzhou, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Sandoz, Teva, Unichem Labs Ltd, Watson Labs Inc, and West-ward Pharms Int, and is included in fifteen NDAs. It is available from seventeen suppliers. Additional details are available on the IRBESARTAN AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in IRBESARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; irbesartan. There are thirty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.
Summary for 091370
Tradename:IRBESARTAN AND HYDROCHLOROTHIAZIDE
Applicant:Alembic Pharms Ltd
Ingredient:hydrochlorothiazide; irbesartan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091370
Ingredient-typeThiazides
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 091370
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRBESARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; irbesartan TABLET;ORAL 091370 ANDA Alembic Pharmaceuticals Limited 46708-442 N 46708-442-90
IRBESARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; irbesartan TABLET;ORAL 091370 ANDA Alembic Pharmaceuticals Limited 46708-442 N 46708-442-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;150MG
Approval Date:Oct 15, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;300MG
Approval Date:Oct 15, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;300MG
Approval Date:Oct 12, 2016TE:ABRLD:No

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