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FDA approval activities for this prescription 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.

For the latest approval information, please locate this API using this index.

 
                                                                                  


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