01 1Mallinckrodt Pharmaceuticals
01 1DIPHENOXYLATE HYDROCHLORIDE USP
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-22
Pay. Date : 2014-03-05
DMF Number : 12441
Submission : 1997-03-31
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 DIPHENOXYLATE HYDROCHLORIDE USP, with a corresponding US DMF Number 12441.
Remarkably, this DMF maintains an Active status since its submission on March 31, 1997, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 22, 2014, and payment made on March 05, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
