|
|
|
 |
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 | Zyrtec (cetirizine HCl) Tablets, Pfizer, Formulation Revision | Cetirizine Hydrochloride Syrup, Ranbaxy Labs, Tentative Approval | Cetirizine Hydrochloride Syrup, Taro Pharma, Tentative Approval | Cetirizine Hydrochloride Tablets, Caraco Pharma, Tentative Approval | Cetirizine Hydrochloride Chewable Tablets, Caraco Pharma, Tentative Approval | Cetirizine Hydrochloride Syrup, Taro Pharma, Tentative Approval | Cetirizine Hydrochloride Tablets, Cipla Ltd., Tentative Approval | Zyrtec-D (cetirizine HCl/pseudoephedrine HCl) Tablets, Pfizer Inc., OTC Labeling Revision | Children’s Zyrtec (cetirizine HCl) Chewable Tablets, McNeil Consumer, OTC Approval | Children’s Zyrtec (cetirizine HCl) Allergy Syrup, McNeil Consumer, OTC Approval | Zyrtec (cetirizine HCl) Tablets, Pfizer, OTC Labeling | Cetirizine Hydrochloride Tablets, Perrigo R&D, Approval | Cetirizine Hydrochloride Tablets, Par Pharma, Approval | Cetirizine Hydrochloride Tablets, Mylan Pharma, Approval | Cetirizine Hydrochloride Tablets, Ranbaxy, Approval | Cetirizine Hydrochloride Tablets, Sandoz Inc., Approval | Cetirizine Hydrochloride Tablets, Caraco Pharma, Approval | Cetirizine Hydrochloride Tablets, Apotex, Approval | Cetirizine Hydrochloride Tablets, Actavis Elizabeth, Approval | Cetirizine Hydrochloride Tablets, Wockhardt, Approval | Cetirizine Hydrochloride, Chewable Tablets, Caraco Pharmaceutical Laboratories, Ltd., Approval | Cetirizine Hydrochloride Chewable Tablets, Caraco Pharma, Approval | Cetirizine Hydrochloride Chewable Tablets, Sandoz Inc., Approval | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Teva Pharma, Approval | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Sandoz Inc., Approval | Children’s Cetirizine Hydrochloride Sryup, Perrigo, Approval | Children's Cetirizine Hydrochloride Allergy Syrup, Taro Pharma, Approval | Children's Cetirizine Hydrochloride Hives Relief Syrup, Taro Pharma, Approval | Children's Cetirizine Hydrochloride Allergy Syrup, Ranbaxy Labs, Approval | Children's Cetirizine Hydrochloride Hives Relief Syrup, Ranbaxy Labs, Approval | Children's Cetirizine Hydrochloride Allergy Syrup, Actavis Mid-Atlantic, LLC, Tentative Approval | Children's Cetirizine Hydrochloride Hives Relief Syrup, Actavis Mid-Atlantic, LLC, Tentative Approval | Cetirizine Hydrochloride Syrup, Teva Pharmaceuticals USA, Approval | Cetirizine Hydrochloride Syrup, Teva Pharmaceuticals USA | Cetirizine Hydrochloride Syrup, Ranbaxy Inc., Approval | Cetirizine Hydrochloride Syrup, Apotex Corp., Approval | Cetirizine Hydrochloride Syrup, Perrigo Israel Pharmaceuticals, Ltd.., Approval | Cetirizine Hydrochloride Syrup, Taro Pharmaceutical Industries, Ltd., Approval | Children's Zyrtec Allergy (cetirizine hydrochloride) Syrup, McNeil-PPC, Inc., Formulation Revision | Children's Zyrtec Allergy (cetirizine hydrochloride) Syrup, McNeil-PPC, Inc., Labeling Revision | Children's Zyrtec Hives Relief (cetirizine hydrochloride) Syrup, McNeil-PPC, Inc., Formulation Revision | Children's Zyrtec Hives Relief (cetirizine hydrochloride) Syrup, McNeil-PPC, Inc., Labeling Revision | Cetirizine Hydrochloride Syrup, Cypress Pharmaceutical, Inc., Approval | Zyrtec (cetirizine hydrochloride) Tablets, McNeil Consumer Healthcare, Manufacturing Change or Addition
|