FDA Approval Activities for this Drug…

Zyrtec (cetirizine hydrochloride) Tablets, 5 and 10 mg, and Syrup, 1mg/ml, Pfizer NDA 19-835/S-015 & 20-346/S-008 10/21/02 10/28/02 10/25/02 Zyrtec (cetirizine HCl) Tablets Pfizer NDA 19-835/S-005 5/15/98 5/15/98 5/22/01 Zyrtec (cetirizine HCl) Syrup Pfizer NDA 20-346/S-002 5/15/98 5/15/98 5/22/01 Zyrtec Indication: These supplements provide for the use of Zyrtec in pediatric patients 2 to 5 years of age for the indications seasonal and perennial allergic rhinitis and chronic idiopathic urticaria. Zyrtec-D 12 hr. Extended-Release Tablets (Cetirizine Hydrochloride & Pseudoephedrine Hydrochloride), Pfizer NDA 21-150/S2 4/14/03 4/18/03 Zyrtec-D 12 hr. Extended-Release Tablets (Cetirizine Hydrochloride & Pseudoephedrine Hydrochloride), 5 mg & 120 mg, Pfizer NDA 21-150 8/10/01 8/14/01 11/6/01 2/28/02 Zyrtec Indication: For the relief of nasal and non-nasal symptoms associated with seasonal or perennial allergic rhinitis in adults and children 12 years of age and older. Zyrtec (cetirizine HCl) Tablets, Pfizer Zyrtec (cetirizine hydrochloride) Tablets, Syrup & Extended-Release Tablets, Pfizer Cetirizine Hydrochloride Tablets, Mylan Pharmaceuticals, Tentative Approval | Cetirizine Hydrochloride Tablets, Teva Pharma, Tentative Approval

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