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Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203630

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NDA 203630 describes IRBESARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Dr Reddys Labs Ltd, Apotex Inc, Macleods Pharms Ltd, Lupin Ltd, Aurobindo Pharma Ltd, Atlas Pharms Llc, Watson Labs Inc, Sandoz, West-ward Pharms Int, Mylan Pharms Inc, Teva, Alembic Pharms Ltd, Prinston Inc, and Hisun Pharm Hangzhou, and is included in fourteen NDAs. It is available from sixteen 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 NDA: 203630

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 203630

Ingredient-typeThiazides
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 203630

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRBESARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL 203630 ANDA Aurobindo Pharma Limited 65862-629 65862-629-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-629-05)
IRBESARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL 203630 ANDA Aurobindo Pharma Limited 65862-629 65862-629-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-629-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;150MG
Approval Date:Feb 22, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;300MG
Approval Date:Feb 22, 2013TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;300MG
Approval Date:Mar 31, 2016TE:ABRLD:No


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