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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Johnson and Johnson
Express Scripts
Federal Trade Commission

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078946

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NDA 078946 describes VALSARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, and Watson Labs Teva, and is included in eight NDAs. It is available from twenty-four suppliers. Additional details are available on the VALSARTAN AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in VALSARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; valsartan. There are thirty-one drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 078946
Applicant:Lupin Ltd
Ingredient:hydrochlorothiazide; valsartan
Formulation / Manufacturing:see details
Pharmacology for NDA: 078946
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 078946
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 078946 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-976 35356-976-30 30 TABLET, FILM COATED in 1 BOTTLE (35356-976-30)
VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 078946 ANDA AvPAK 50268-790 50268-790-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-790-15) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-790-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;320MG
Approval Date:Mar 21, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;320MG
Approval Date:Mar 21, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;80MG
Approval Date:Mar 21, 2013TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
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