01 1Mallinckrodt Pharmaceuticals
01 1DEXTROAMPHETAMINE SULFATE USP NP
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-09-24
Pay. Date : 2025-09-04
DMF Number : 41348
Submission : 2025-08-28
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 DEXTROAMPHETAMINE SULFATE USP NP, with a corresponding US DMF Number 41348.
Remarkably, this DMF maintains an Active status since its submission on August 28, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 24, 2025, and payment made on September 04, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
