01 1Mallinckrodt Pharmaceuticals
01 1LISDEXAMFETAMINE DIMESYLATE
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-07-28
Pay. Date : 2020-06-03
DMF Number : 34823
Submission : 2020-05-29
Status : Active
Type : II
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Specgx Llc, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is LISDEXAMFETAMINE DIMESYLATE, with a corresponding US DMF Number 34823.
Remarkably, this DMF maintains an Active status since its submission on May 29, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 28, 2020, and payment made on June 03, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
