01 1Mallinckrodt Pharmaceuticals
01 1CODEINE SULFATE USP POWDER
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-04
Pay. Date : 2014-07-28
DMF Number : 21117
Submission : 2007-11-30
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 CODEINE SULFATE USP POWDER, with a corresponding US DMF Number 21117.
Remarkably, this DMF maintains an Active status since its submission on November 30, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 04, 2014, and payment made on July 28, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
