The estimated duration of the interim limit in Table 3 was updated from 8/1/2026 to 8/1/2027. The problem has been ongoing.
Table 3
Revision Table
The estimated duration of the interim limit in Table 3 was updated from 8/1/2026 to 8/1/2027. The problem has been ongoing.
Table 3
Revision Table
At least now, requesting FDA to make AI limit inline with EMA for N-nitroso-dorzolamide “NDRZ”….this has been more than two years now EMA has published AI limit for NDRZ based on study and products are commercial.