Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.