01 1Mallinckrodt Pharmaceuticals
01 1HYDROCODONE BITARTRATE USP CRYSTALS (NP)
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-23
Pay. Date : 2013-11-25
DMF Number : 25961
Submission : 2013-10-31
Status : Active
Type : II
20
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 HYDROCODONE BITARTRATE USP CRYSTALS (NP), with a corresponding US DMF Number 25961.
Remarkably, this DMF maintains an Active status since its submission on October 31, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 23, 2014, and payment made on November 25, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
