01 1Mallinckrodt Pharmaceuticals
01 1LEVORPHANOL TARTRATE USP SPECIAL
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-21
Pay. Date : 2017-09-08
DMF Number : 18823
Submission : 2005-09-29
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 LEVORPHANOL TARTRATE USP SPECIAL, with a corresponding US DMF Number 18823.
Remarkably, this DMF maintains an Active status since its submission on September 29, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 21, 2017, and payment made on September 08, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
