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… Trileptal (oxcarbazepine) Tablets, Novartis Pharmaceutical NDA 21-014/S-003 8/7/03 8/15/03 Trileptal (oxcarbazepine) Tablets and Suspension, Novartis Pharmaceutical NDA 21-014/S-007 & 21-285/S-004 Trileptal (Oxcarbazepine) Tablets & Suspension, Novartis NDA 21-014/S6 & 21-285/S2 4/1/02 4/8/02 Trileptal (oxcarbazepine) Tablets, Novartis NDA 21-014/S3 8/7/03 8/15/03 Trileptal (oxcarbazepine) Tablets, Novartis NDA 21-014 1/10/99 1/19/00 1/19/00 2/28/02 Trileptal (oxcarbazepine) Tablets and Suspension, Novartis NDA 21-014/S-007 & 21-285/S-004   For the latest approval information, locate this drug using this index.