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… Alrex (Loteprednol Etabonate) Ophthalmic Suspension, 0.2% Bausch and Lomb NDA 20803 Lotemax (Loteprednol Etabonate), 0.5% Bausch and Lomb NDA 20-841 3/9/98 3/9/98 6/25/98 4/11/02 Lotemax (Loteprednol Etabonate), Ophthalmic Suspension, 0.5% Pharmos NDA 20-583   For the latest approval information, locate this drug using this index.