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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Baxter
US Army
Queensland Health
Boehringer Ingelheim
Farmers Insurance
Cipla
Accenture
Dow
Mallinckrodt

Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087294

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NDA 087294 describes HYDROXYZINE HYDROCHLORIDE, which is a drug marketed by Vintage, Eci Pharms Llc, Elite Labs Inc, Hetero Labs Ltd Iii, Pharmafair, Luitpold, Amneal Pharm, Mutual Pharm, Solopak, Hi Tech Pharma, Ivax Pharms, Invagen Pharms, Hospira, Halsey, Pliva, Kv Pharm, Bayshore Pharms Llc, Purepac Pharm, Nuvo Pharm Inc, Usl Pharma, Watson Labs, Fresenius Kabi Usa, Quantum Pharmics, Northstar Hlthcare, Sandoz, Baxter Hlthcare, Wyeth Ayerst, Able, Sun Pharm Inds, Actavis Elizabeth, Aurolife Pharma Llc, Altana, Silarx Pharms Inc, Prinston Inc, Mylan, Heritage Pharma, Sti Pharma Llc, Alpharma Us Pharms, Kvk Tech, Vintage Pharms, Smith And Nephew, Wockhardt, Superpharm, and Sun Pharm Inds Inc, and is included in one hundred and four NDAs. It is available from fifty-two 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. Fifty-two suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

Summary for NDA: 087294

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

Pharmacology for NDA: 087294

Suppliers and Packaging for NDA: 087294

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride
SYRUP;ORAL 087294 ANDA Pharmaceutical Associates, Inc. 0121-4822 0121-4822-12 4 TRAY in 1 CASE (0121-4822-12) > 10 CUP, UNIT-DOSE in 1 TRAY > 12.5 mL in 1 CUP, UNIT-DOSE
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride
SYRUP;ORAL 087294 ANDA Pharmaceutical Associates, Inc. 0121-4822 0121-4822-25 4 TRAY in 1 CASE (0121-4822-25) > 10 CUP, UNIT-DOSE in 1 TRAY > 25 mL in 1 CUP, UNIT-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength10MG/5ML
Approval Date:Apr 12, 1982TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Healthtrust
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Queensland Health
Harvard Business School
Argus Health
McKinsey
McKesson
Daiichi Sankyo
Cerilliant
UBS

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