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Last Updated: May 28, 2024

Details for New Drug Application (NDA): 021150


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NDA 021150 describes ZYRTEC-D 12 HOUR, which is a drug marketed by J And J Consumer Inc and is included in one NDA. It is available from one supplier. Additional details are available on the ZYRTEC-D 12 HOUR profile page.

The generic ingredient in ZYRTEC-D 12 HOUR is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 021150
Pharmacology for NDA: 021150
Suppliers and Packaging for NDA: 021150
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYRTEC-D 12 HOUR cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021150 NDA Johnson & Johnson Consumer Inc. 50580-719 50580-719-12 2 BLISTER PACK in 1 CARTON (50580-719-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
ZYRTEC-D 12 HOUR cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021150 NDA Johnson & Johnson Consumer Inc. 50580-719 50580-719-24 4 BLISTER PACK in 1 CARTON (50580-719-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG;120MG
Approval Date:Nov 9, 2007TE:RLD:Yes

Expired US Patents for NDA 021150

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc ZYRTEC-D 12 HOUR cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021150-002 Nov 9, 2007 ⤷  Sign Up ⤷  Sign Up
J And J Consumer Inc ZYRTEC-D 12 HOUR cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021150-002 Nov 9, 2007 ⤷  Sign Up ⤷  Sign Up
J And J Consumer Inc ZYRTEC-D 12 HOUR cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021150-002 Nov 9, 2007 ⤷  Sign Up ⤷  Sign Up
J And J Consumer Inc ZYRTEC-D 12 HOUR cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021150-002 Nov 9, 2007 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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