Registration Dossier

Administrative data

Endpoint:
carcinogenicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Data source

Reference
Reference Type:
other: FDA review
Title:
Centre for drug evaluation and Research Appoval Package For Application Number 21-468
Author:
FDA
Year:
2004
Bibliographic source:
US FDA online data base

Materials and methods

Results and discussion

Applicant's summary and conclusion