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US Army
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Generated: October 20, 2017

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 Dr Reddys Labs Ltd, Apotex Inc, Macleods Pharms Ltd, Unichem Labs 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 fifteen NDAs. It is available from fifteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.

Summary for NDA: 091370

Tradename:
1
Applicant:
1
Ingredient:
1
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 Inc. 62332-051 62332-051-10 10 TABLET in 1 BLISTER PACK (62332-051-10)
IRBESARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL 091370 ANDA Alembic Pharmaceuticals Inc. 62332-051 62332-051-30 30 TABLET in 1 BOTTLE (62332-051-30)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Farmers Insurance
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