01 1Vertellus
01 1NIACIN USP
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-12
Pay. Date : 2022-09-28
DMF Number : 8259
Submission : 1989-10-17
Status : Active
Type : II
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Aurorium Llc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is NIACIN USP, with a corresponding US DMF Number 8259.
Remarkably, this DMF maintains an Active status since its submission on October 17, 1989, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 12, 2022, and payment made on September 28, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
