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Details for New Drug Application (NDA): 201505

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NDA 201505 describes IRBESARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Dr Reddys Labs Ltd, Apotex Inc, Macleods Pharms Ltd, Lupin Ltd, Aurobindo Pharma Ltd, Intl Speclt Chems, Watson Labs Inc, Sandoz, Roxane, Mylan Pharms Inc, Teva, Alembic Pharms Ltd, and Prinston Inc, and is included in thirteen 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. There are four tentative approvals for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.

Summary for NDA: 201505

Pharmacology for NDA: 201505

Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 201505

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydrochlorothiazide; irbesartan
TABLET;ORAL 201505 ANDA Apotex Corp. 60505-3603 60505-3603-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-3603-3)
hydrochlorothiazide; irbesartan
TABLET;ORAL 201505 ANDA Apotex Corp. 60505-3603 60505-3603-9 90 TABLET, FILM COATED in 1 BOTTLE (60505-3603-9)

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

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