Is it possible to have 2 drugs with same NDA number

Question

I am facing a very peculiar issue with the USFDA database. There is one NDA number 050790 corresponding to 2 different drug names viz. Restasis and Restasis multidose! Both the drugs have different patents.

If I were to download these data from the API, my database will get confused as to which patents are applicable to which drugs. Also when generics of these drugs will come, how will we know which one is the RLD for the approved generic (assuming approval letters are not uploaded).

Answer 1

Yes, as you can see, an NDA application can have more than one product on it, which makes NDA number not the best choice for identifying a specific drug product. You are much better off relying on other unique drug identifiers, such as NDC or SPL ID.