01 1Mallinckrodt Pharmaceuticals
01 1HYDROMORPHONE HYDROCHLORIDE USP (NP)
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-13
Pay. Date : 2012-11-27
DMF Number : 25766
Submission : 2012-07-25
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 HYDROMORPHONE HYDROCHLORIDE USP (NP), with a corresponding US DMF Number 25766.
Remarkably, this DMF maintains an Active status since its submission on July 25, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 13, 2013, and payment made on November 27, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
