Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com