FDA Approval Activities for this Drug…

Itraconazole Capsules, 100 mg, Eon Labs Manufacturing, ANDA 76-104 Sporanox (itraconazole) Capsules, Johnson and Johnson Pharmaceutical Research and Development. L.L.C NDA 20-083/S25 5/09/01 4/25/03 Sporanox (itraconazole) Capsules, 100 mg, Johnson and Johnson Pharmaceutical Research and Development. L.L.C. NDA 20-083/S28 & S31 7/17/02 7/24/02 7/19/02 Sporanox (itraconazole) Capsules, 400 mg, (Patient Information) Johnson and Johnson Pharmaceutical Research and Development. L.L.C. NDA 20-083/S29 4/11/02 4/16/02 5/9/02 Sporanox (itraconazole) Injection, 10mg/mL, Johnson and Johnson Pharmaceutical Research and Development. L.L.C. NDA 20-966/S6 7/17/02 7/24/02 7/19/02 Sporanox (itraconazole) Injection, 10mg/mL, Johnson and Johnson Pharmaceutical Research and Development. L.L.C. NDA 20-966/S5 2/28/02 3/7/02 Sporanox (itraconazole) Solution, 10mg/mL, Janssen Research Foundation NDA 20-657/S8 7/17/02 7/24/02 7/19/02 Sporanox (itraconazole) Solution, Johnson & Johnson NDA 20-657/S10 9/24/03 9/30/03 9/30/03 Sporanox (itraconazole) Solution, 10mg/mL, Johnson & Johnson Pharmaceutical NDA 20-657/S7 9/11/02 9/18/02 9/12/02 Sporanox (itraconazole) Injection & Solution, 10mg/mL, Janssen Research Foundation NDA 20-966/S1,3 & 4 & 20657/S4 & 5 4/17/01 4/25/03 10/26/01 Sporanox (itraconazole) Injection, 10mg/mL injection, Janssen Research Foundation NDA 20-966 Sporanox (itraconazole) Capsules, Johnson and Johnson Itraconazole Capsules, Eon Labs Sporanox (itraconazole) Capsules, Johnson & Johnson, Labeling Revision Sporanox (itraconazole) Injection, Johnson & Johnson, Labeling Revision

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