01 1Ascensus Specialties
01 1DEXMEDETOMIDINE HYDROCHLORIDE USP
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-26
Pay. Date : 2023-09-06
DMF Number : 38248
Submission : 2023-09-21
Status : Active
Type : II
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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 DEXMEDETOMIDINE HYDROCHLORIDE USP, with a corresponding US DMF Number 38248.
Remarkably, this DMF maintains an Active status since its submission on September 21, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 26, 2024, and payment made on September 06, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
