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New! As of May 1, 2004, New and Generic Drug Approvals 1998-2004,
will not be updated. |
| Product Name | Company | Application # | Approval Date |
Letter |
Label Posted |
Review Posted |
|---|---|---|---|---|---|---|
| Xalatan (latanoprost) ophthalmic solution, 0.005%, | Pharmacia & Upjohn Company | NDA 20-597/S28 & S29 | 7/14/03 | 7/28/03 | ||
| Xalatan (latanoprost) ophthalmic solution, 0.005%, | Pharmacia & Upjohn Company | NDA 20-597/S-025 | 8/26/02 | 8/30/02 | 8/26/02 | |
| Xalatan (latanoprost) ophthalmic solution, 0.005%, | Pharmacia & Upjohn Company | NDA 20-597/S-023 | 11/26/01 | 4/28/03 | ||
| Xalatan (latanoprost) ophthalmic solution, 0.005%, | Pharmacia & Upjohn Company | NDA 20-597/S-019 | 8/8/01 | 4/28/03 | ||
| Xalatan (latanoprost) ophthalmic solution, 0.005%, | Pharmacia & Upjohn Company | NDA 20-597/S-010 | 12/20/02 | 1/29/03 | 4/3/03 | |
| XANAX XR (alprazolam) Extended-release Tablets & Tablets, Rx | Pfizer, Inc. | NDA 21-434/S1 & 18-276/S38 & S39 | 4/2/04 | 4/7/04 | ||
| XANAX XR (alprazolam) Extended-release Tablets, Rx | Pharmacia & Upjohn | NDA 21-434 | 1/17/03 | 1/23/03 | 1/23/03 | |
| Xeloda (Capecitabine) Tablets, Rx | Hoffman-LaRoche Inc | NDA 20-896/S12 | 3/15/03 | 3/26/03 | 3/26/03 | |
| Xeloda (Capecitabine) Tablets, Rx | Roche | NDA 20-896/S10 & 11 | 9/7/01 | 11/6/01 | 9/12/01 | 11/7/01 |
| Xeloda Indications: For the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthacycline containing chemotherapy. SLR-011 added a black box warning for drug-drug interaction with warfarin. | ||||||
| Xeloda capecitabine Tablets, 150 mg and 500 mg, Rx | Roche | NDA 20-896/S6, S9 | 4/30/01 | 2/6/02 | 04/25/03 | 2/6/02 |
| Xeloda capecitabine Tablets, 150 mg and 500 mg, Rx | Hoffman-La Roche | NDA 20-896 | 4/30/98 | 5/6/98 | 11/28/00 | 2/4/99 |
| Xenical (Orlistat) Capsules, | Hoffmann-La Roche | NDA 20766/S18 | 12/12/03 | 12/19/03 | 12/29/03 | |
| Xenical/Orlistat Capsules, 120 mg | Roche Laboratories Inc. | NDA 20766/S7 | 6/25/01 | 6/25/01 | ||
| Xenical/Orlistat Capsules, 120 mg [patient instructions] | Roche Laboratories | NDA 20-766 | 4/26/99 | 4/27/99 | 4/27/99 | 8/13/99 |
| Indication: XENICAL (orlistat) is a lipase inhibitor for obesity management that acts by inhibiting the absorption of dietary fats. | ||||||
| Xenon X-133 Gas, | Bristol-Meyers Squibb | NDA 17-284\SLR-009 | 10/27/03 | 10/31/03 | ||
| Xopenex (levalbuterol HCl) Inhalation Solution, |
Sepracor Inc. |
NDA 20-837/S10 | 7/18/03 | 7/28/03 | ||
| Xopenex (levalbuterol HCl) Inhalation Solution, 0.31 mg/3 mL, 0.63 mg/3 mL & 1.25 mg/3 mL Unit-Dose Vials Sepracor Inc |
Sepracor Inc. |
NDA 20-837/S6 | 1/30/02 | 2/8/02 | ||
| Xopenex Indications: For the treatment or prevention of bronchospasm in children 6 years of age and older with reversible obstructive airway disease. | ||||||
| Xopenex (levalbuterol HCl) Inhalation Solution, 0.63 mg/3 mL & 1.25 mg/3 mL Unit-Dose Vials | Sepracor Inc. | NDA 20-837 | 3/25/99 | 3/29/99 | 3/29/99 | 6/20/01 |
| Xopenex Indications: For the treatment or prevention of bronchospasm in adults and adolescents 12 years of age and older with reversible obstructive airway disease. | ||||||
| Xyrem (sodium oxybate) oral solution, Rx | Orphan Medical | NDA 21-196/S1 | 11/4/03 | 11/25/03 | ||
| Xyrem (sodium oxybate) oral solution, Rx | Orphan Medical | NDA 21-196 | 7/17/02 | 7/24/02 | 7/18/02 | 10/23/02 |
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