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Details for New Drug Application (NDA): 040579

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NDA 040579 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, Purepac Pharm, Usl Pharma, Watson Labs, Fresenius Kabi Usa, Quantum Pharmics, Northstar Hlthcare, Sandoz, Baxter Hlthcare, Wyeth Ayerst, Able, Sun Pharm Inds, Aurolife Pharma Llc, Actavis Elizabeth, Altana, Silarx Pharms Inc, Vintage Pharms, Mylan, Heritage Pharma, Sti Pharma Llc, Alpharma Us Pharms, Kvk Tech, Smith And Nephew, Wockhardt, Superpharm, and Sun Pharm Inds Inc, and is included in one hundred and three 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-three suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

Summary for NDA: 040579

Tradename:
HYDROXYZINE HYDROCHLORIDE
Applicant:
Vintage Pharms
Ingredient:
hydroxyzine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 040579

Suppliers and Packaging for NDA: 040579

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride
TABLET;ORAL 040579 ANDA Qualitest Pharmaceuticals 0603-3967 0603-3967-21 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-3967-21)
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride
TABLET;ORAL 040579 ANDA Qualitest Pharmaceuticals 0603-3967 0603-3967-28 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-3967-28)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 27, 2005TE:ABRLD:No


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