The documents in this section relate to the approval by FDA of Lariam® (mefloquine) and to certain regulatory issues. The documents were obtained under the Freedom of Information Act and are published as a public service. Any questions about these documents should be addressed to FDA or to the author(s).
- FDA EIR 2002- 2003 Adverse Event Reporting Problems
- FDA NDA-019591 1989 Pharm Rev Corporate
- FDA NDA-0195911989 Med Rev Corporate
- FDA NDA-0195911989 Label
- FDA NDA-0195911989 Chem Rev Corporate
- FDA NDA-0195911989 Approv Letter Corporate
- FDA NDA-019578 1989 Complete Approv Pkg Arm Pivota Trials