01 1Mallinckrodt Pharmaceuticals
01 1DEXMETHYLPHENIDATE HYDROCHLORIDE
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-22
Pay. Date : 2018-04-06
DMF Number : 30657
Submission : 2016-10-07
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 DEXMETHYLPHENIDATE HYDROCHLORIDE, with a corresponding US DMF Number 30657.
Remarkably, this DMF maintains an Active status since its submission on October 07, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 22, 2018, and payment made on April 06, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
