An applicant is required to submit patent information when approval is sought in which of the following supplements submitted
to an approved marketing application?
A Change in the formulation,
B Change in manufacturing site,
C Change in the sponsor,
D Change in the formulation and in the manufanufacturing site
Change in the formulation
An applicant is required to submit patent information when approval is sought in supplements involving a formulation change, a new condition of use, a new indication, a change in the route of administration, a change in strength or any other patented change regarding the drug, drug product, or method of use.