01 1Mallinckrodt Pharmaceuticals
01 1FENTANYL CITRATE (NEW PROCESS)
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-12
Pay. Date : 2012-11-27
DMF Number : 10128
Submission : 1993-03-15
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 FENTANYL CITRATE (NEW PROCESS), with a corresponding US DMF Number 10128.
Remarkably, this DMF maintains an Active status since its submission on March 15, 1993, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 12, 2013, and payment made on November 27, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
