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Generated: August 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090255

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NDA 090255 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, Frontida Biopharm, Akorn, Abraxis Pharm, Luitpold, Par Pharm, Sciegen Pharms Inc, 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, Sandoz, Vitarine, Solvay, and Ivax Pharms, and is included in ninety-one NDAs. It is available from forty-two suppliers. Additional details are available on the HYDRALAZINE HYDROCHLORIDE profile page.

The generic ingredient in HYDRALAZINE HYDROCHLORIDE 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: 090255

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

Pharmacology for NDA: 090255

Physiological EffectArteriolar Vasodilation

Suppliers and Packaging for NDA: 090255

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDRALAZINE HYDROCHLORIDE
hydralazine hydrochloride
TABLET;ORAL 090255 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-205 43353-205-05 4200 TABLET in 1 BOTTLE (43353-205-05)
HYDRALAZINE HYDROCHLORIDE
hydralazine hydrochloride
TABLET;ORAL 090255 ANDA Golden State Medical Supply, Inc. 60429-064 60429-064-01 100 TABLET in 1 BOTTLE (60429-064-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 15, 2008TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Dec 15, 2008TE:AARLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Dec 15, 2008TE:AARLD:No


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Express Scripts

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