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Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204680

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NDA 204680 describes HYDRALAZINE HYDROCHLORIDE, which is a drug marketed by Hetero Labs Ltd Iii, Watson Labs, Mutual Pharm, Vangard, X-gen Pharms Inc, Ascot, Mylan, Solopak, Smith And Nephew, Halsey, Impax Labs, Glenmark Pharms Ltd, Anda Repository, Akorn, Abraxis Pharm, Luitpold, Par Pharm, Tech Organized, Alkem Labs Ltd, Ivax Sub Teva Pharms, Navinta Llc, West Ward, Upsher-smith Labs, Heritage Pharms Inc, Cadila Pharms Ltd, Tg United Labs, Actavis Elizabeth, Usl Pharma, Quantum Pharmics, Invagen Pharms, Pliva, Strides Pharma, Teva Parenteral, Purepac Pharm, Actavis Grp Ptc, Mylan Institutional, Superpharm, Fresenius Kabi Usa, Vitarine, Solvay, and Ivax Pharms, and is included in ninety-one NDAs. It is available from forty-five 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 NDA: 204680

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204680

Physiological EffectArteriolar Vasodilation

Suppliers and Packaging for NDA: 204680

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDRALAZINE HYDROCHLORIDE
hydralazine hydrochloride
INJECTABLE;INJECTION 204680 ANDA Mylan Institutional LLC 67457-291 67457-291-01 25 VIAL, SINGLE-DOSE in 1 CARTON (67457-291-01) > 1 mL in 1 VIAL, SINGLE-DOSE (67457-291-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Apr 28, 2016TE:APRLD:No


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