01 1Mallinckrodt Pharmaceuticals
01 1NALOXONE HCL USP DIHYDRATE
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-11
Pay. Date : 2012-12-07
DMF Number : 1862
Submission : 1972-01-25
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 NALOXONE HCL USP DIHYDRATE, with a corresponding US DMF Number 1862.
Remarkably, this DMF maintains an Active status since its submission on January 25, 1972, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 11, 2013, and payment made on December 07, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
