01 1Mallinckrodt Pharmaceuticals
01 1DEXTROAMPHETAMINE SULFATE USP
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-17
Pay. Date : 2013-03-11
DMF Number : 15385
Submission : 2001-04-18
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, with a corresponding US DMF Number 15385.
Remarkably, this DMF maintains an Active status since its submission on April 18, 2001, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 17, 2013, and payment made on March 11, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
