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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Cipla
Dow
Queensland Health
Julphar
Johnson and Johnson
Cantor Fitzgerald
Covington
Boehringer Ingelheim

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040388

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NDA 040388 describes HYDRALAZINE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Akorn, Fresenius Kabi Usa, Luitpold, Mylan Institutional, Navinta Llc, Smith And Nephew, Solopak, Teva Parenteral, X-gen Pharms Inc, Actavis Elizabeth, Actavis Grp Ptc, Alkem Labs Ltd, Anda Repository, Ascot, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Halsey, Heritage Pharms Inc, Hetero Labs Ltd Iii, Impax Labs, Invagen Pharms, Ivax Sub Teva Pharms, Mutual Pharm, Mylan, Par Pharm, Pliva, Purepac Pharm, Quantum Pharmics, Sciegen Pharms Inc, Strides Pharma, Superpharm, Upsher-smith Labs, Usl Pharma, Vangard, Vitarine, Watson Labs, West Ward, Solvay, and Ivax Pharms, and is included in ninety-one NDAs. It is available from forty suppliers. Additional details are available on the HYDRALAZINE HYDROCHLORIDE profile page.

The generic ingredient in HYDRALAZINE HYDROCHLORIDE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are twenty drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.
Summary for 040388
Tradename:HYDRALAZINE HYDROCHLORIDE
Applicant:Fresenius Kabi Usa
Ingredient:hydralazine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040388
Physiological EffectArteriolar Vasodilation
Medical Subject Heading (MeSH) Categories for 040388
Suppliers and Packaging for NDA: 040388
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride INJECTABLE;INJECTION 040388 ANDA General Injectables & Vaccines, Inc 52584-614 N 52584-614-01
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride INJECTABLE;INJECTION 040388 ANDA Cardinal Health 55154-9367 N 55154-9367-5

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Mar 13, 2001TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Fuji
McKinsey
Mallinckrodt
Queensland Health
QuintilesIMS
Baxter
Farmers Insurance
Accenture

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