This is in response to a request from Mr. David W. Beier, III,

Assistant Counsel of the Subcommittee, for information on the number of new drug applications approved from 1979 to date.

Enclosed is a listing of all new drug applications (NDA) approved from 1979 through May 1984. The NDA number, generic name, trade name, dosage form, applicant name, indication and approval date are included in the list.

Mr. Beier also requested that we identify the new chemical entities
that were approved during that time.

The classification nomenclature we use is new molecular entity, not new
chemical entity. The classification description attached to the list
defines a new molecular entity which, in the list, is designated by the
number 1". The letter designation refers only to therapeutic
potential. All other numerical designations are for non new molecular
entities.

If you have any questions regarding this list, please let me know.