Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021150

ZYRTEC-D 12 HOUR (CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE)
5MG;120MG Marketing Status: Over-the-counter

Active Ingredient: CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: ZYRTEC-D 12 HOUR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG;120MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021150
Product Number: 002
Approval Date: Nov 9, 2007
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

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