01 1Mallinckrodt Pharmaceuticals
01 1NALTREXONE BASE
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-13
Pay. Date : 2019-02-08
DMF Number : 9572
Submission : 1992-03-03
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 NALTREXONE BASE, with a corresponding US DMF Number 9572.
Remarkably, this DMF maintains an Active status since its submission on March 03, 1992, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 13, 2019, and payment made on February 08, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
