01 1Mallinckrodt Pharmaceuticals
01 1FENTANYL ALKALOID
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-25
Pay. Date : 2012-11-27
DMF Number : 14285
Submission : 1999-06-30
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 FENTANYL ALKALOID, with a corresponding US DMF Number 14285.
Remarkably, this DMF maintains an Active status since its submission on June 30, 1999, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 25, 2013, and payment made on November 27, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
