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Queensland Health
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Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077969

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NDA 077969 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: 077969

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

Pharmacology for NDA: 077969

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

Suppliers and Packaging for NDA: 077969

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRBESARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL 077969 ANDA Mylan Pharmaceuticals Inc. 0378-3033 0378-3033-77 90 TABLET in 1 BOTTLE, PLASTIC (0378-3033-77)
IRBESARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL 077969 ANDA Mylan Pharmaceuticals Inc. 0378-3034 0378-3034-77 90 TABLET in 1 BOTTLE, PLASTIC (0378-3034-77)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;300MG
Approval Date:Jul 20, 2016TE:ABRLD:No


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Dow
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