01 1Mallinckrodt Pharmaceuticals
01 1DEXTROAMPHETAMINE SACCHARATE
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-08
Pay. Date : 2013-05-31
DMF Number : 15428
Submission : 2001-05-15
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 SACCHARATE, with a corresponding US DMF Number 15428.
Remarkably, this DMF maintains an Active status since its submission on May 15, 2001, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 08, 2013, and payment made on May 31, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
