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Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087408

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NDA 087408 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, Nuvo Pharm Inc, Purepac Pharm, 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 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 suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

Summary for NDA: 087408

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

Pharmacology for NDA: 087408

Suppliers and Packaging for NDA: 087408

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride
INJECTABLE;INJECTION 087408 ANDA American Regent, Inc. 0517-4201 0517-4201-25 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4201-25) > 1 mL in 1 VIAL, SINGLE-DOSE
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride
INJECTABLE;INJECTION 087408 ANDA American Regent, Inc. 0517-5601 0517-5601-25 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-5601-25) > 1 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
QuintilesIMS
Boehringer Ingelheim
Accenture
Julphar
Farmers Insurance
Teva
Queensland Health
Fuji

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