01 1Mallinckrodt Pharmaceuticals
01 1METHYLNALTREXONE BROMIDE, CODE 1251
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-08
Pay. Date : 2014-07-28
DMF Number : 22553
Submission : 2009-02-16
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 METHYLNALTREXONE BROMIDE, CODE 1251, with a corresponding US DMF Number 22553.
Remarkably, this DMF maintains an Active status since its submission on February 16, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 08, 2014, and payment made on July 28, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
