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Details for New Drug Application (NDA): 084325

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NDA 084325 describes HYDROCHLOROTHIAZIDE, which is a drug marketed by Leading Pharma Llc, Watson Labs, Roxane, Ivax Sub Teva Pharms, Vintage Pharms, Actavis Elizabeth, Impax Labs, Ipca Labs Ltd, Unichem, Jubilant Cadista, Whiteworth Town Plsn, Sun Pharm Inds Inc, Vangard, Mylan, Sandoz, Sciegen Pharms Inc, Aurolife Pharma Llc, Solvay, Teva, Lannett, Superpharm, Usl Pharma, Heather, Mylan Pharms Inc, Ascot, Alembic Pharms Ltd, Elkins Sinn, Alra, Accord Hlthcare, Dava Pharms Inc, Morton Grove, Lannett Holdings Inc, Aurobindo Pharma, Tg United Labs, Inwood Labs, Barr, Abc Holding, Sun Pharm Inds, Apotex, Hikma Intl Pharms, Heritage Pharms Inc, Warner Chilcott, Mast Mm, Pvt Form, West Ward, and Pharmeral, and is included in one hundred and nine NDAs. It is available from seventy-two suppliers. Additional details are available on the HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in HYDROCHLOROTHIAZIDE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are nineteen drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.

Summary for NDA: 084325

Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 084325

Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 084325

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 084325 ANDA Lannett Company, Inc. 0527-1413 0527-1413-01 100 TABLET in 1 BOTTLE, PLASTIC (0527-1413-01)
TABLET;ORAL 084325 ANDA Lannett Company, Inc. 0527-1413 0527-1413-10 1000 TABLET in 1 BOTTLE, PLASTIC (0527-1413-10)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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