01 1Mallinckrodt Pharmaceuticals
01 1NALMEFENE HYDROCHLORIDE
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-25
Pay. Date : 2019-08-22
DMF Number : 15663
Submission : 2001-10-10
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 NALMEFENE HYDROCHLORIDE, with a corresponding US DMF Number 15663.
Remarkably, this DMF maintains an Active status since its submission on October 10, 2001, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 25, 2019, and payment made on August 22, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
