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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Argus Health
Daiichi Sankyo

Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202414

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NDA 202414 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 202414
Applicant:Macleods Pharms Ltd
Ingredient:hydrochlorothiazide; irbesartan
Formulation / Manufacturing:see details
Pharmacology for NDA: 202414
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 202414
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRBESARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; irbesartan TABLET;ORAL 202414 ANDA Macleods Pharmaceuticals Limited 33342-057 N 33342-057-07
IRBESARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; irbesartan TABLET;ORAL 202414 ANDA Macleods Pharmaceuticals Limited 33342-057 N 33342-057-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;150MG
Approval Date:Sep 27, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;300MG
Approval Date:Sep 27, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Daiichi Sankyo
Johnson and Johnson
Chinese Patent Office
Queensland Health

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