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Generated: May 24, 2017

DrugPatentWatch Database Preview

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 two suppliers. There are three patents protecting this drug. 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. Thirty-four suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for NDA: 021150

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

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., McNeil Consumer Healthcare Division 50580-728 50580-728-12 2 BLISTER PACK in 1 CARTON (50580-728-12) > 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
ZYRTEC-D 12 HOUR
cetirizine hydrochloride; pseudoephedrine hydrochloride
 TABLET, EXTENDED RELEASE;ORAL 021150 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 50580-728 50580-728-24 4 BLISTER PACK in 1 CARTON (50580-728-24) > 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG;120MG
Approval Date:Nov 9, 2007TE:RLD:Yes
Patent:7,014,867Patent Expiration:Jun 10, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:6,469,009Patent Expiration:Jul 13, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
Patent:7,226,614Patent Expiration:Jun 10, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS

Expired Orange Book 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;ORAL021150-002Nov 9, 20076,489,329► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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