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Details for New Drug Application (NDA): 202414

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NDA 202414 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, 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. There are four tentative approvals for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.

Summary for NDA: 202414

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
hydrochlorothiazide; irbesartan
TABLET;ORAL 202414 ANDA Macleods Pharmaceuticals Limited 33342-057 33342-057-06 3 BLISTER PACK in 1 CARTON (33342-057-06) > 10 TABLET, FILM COATED in 1 BLISTER PACK
hydrochlorothiazide; irbesartan
TABLET;ORAL 202414 ANDA Macleods Pharmaceuticals Limited 33342-057 33342-057-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-057-07)

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

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