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Last Updated: August 10, 2020

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Details for New Drug Application (NDA): 087871

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NDA 087871 describes HYDROXYZINE HYDROCHLORIDE, which is a drug marketed by Altana, Am Regent, Baxter Hlthcare, Dr Reddys, Fresenius Kabi Usa, Hospira, Pharmafair, Smith And Nephew, Solopak, Watson Labs, Wyeth Ayerst, Alpharma Us Pharms, Anima, Hi Tech Pharma, Kv Pharm, Lannett Co Inc, Torrent, Vintage Pharms, Wockhardt Bio Ag, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Eci Pharms Llc, Epic Pharma Llc, Halsey, Heritage Pharma, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Pharms, Kvk Tech, Mutual Pharm, Mylan, Northstar Hlthcare, Nuvo Pharm, Nuvo Pharms Inc, Pliva, Prinston Inc, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Usl Pharma, and Vintage, and is included in one hundred and three NDAs. It is available from thirty-seven suppliers. Additional details are available on the HYDROXYZINE HYDROCHLORIDE profile page.

The generic ingredient in HYDROXYZINE HYDROCHLORIDE is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
Summary for 087871
Tradename:HYDROXYZINE HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:hydroxyzine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Dec 20, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Dec 20, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG
Approval Date:Dec 20, 1982TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
McKesson
Johnson and Johnson
Merck
Mallinckrodt

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