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Details for New Drug Application (NDA): 022578

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NDA 022578 describes ZYRTEC ALLERGY, which is a drug marketed by J And J Consumer Inc and is included in two NDAs. It is available from four suppliers. Additional details are available on the ZYRTEC ALLERGY profile page.

The generic ingredient in ZYRTEC ALLERGY is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and sixty-two suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

Summary for NDA: 022578

Tradename:
ZYRTEC ALLERGY
Applicant:
J And J Consumer Inc
Ingredient:
cetirizine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022578

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYRTEC ALLERGY
cetirizine hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL 022578 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 50580-778 50580-778-12 2 BLISTER PACK in 1 CARTON (50580-778-12) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
ZYRTEC ALLERGY
cetirizine hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL 022578 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 50580-778 50580-778-24 4 BLISTER PACK in 1 CARTON (50580-778-24) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:Sep 3, 2010TE:RLD:Yes


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