01 1Ascensus Specialties
01 1FOMEPIZOLE
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-09-17
Pay. Date : 2024-07-11
DMF Number : 40058
Submission : 2024-07-24
Status : Active
Type : II
20
Ascensus Specialties Llc, based in U.S.A, is a pharmaceutical company.
They are recognized for Ascensus Specialties has expertise in manufacturing APIs & Intermediates in the US.
One of their notable products is FOMEPIZOLE, with a corresponding US DMF Number 40058.
Remarkably, this DMF maintains an Active status since its submission on July 24, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 17, 2024, and payment made on July 11, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
