01 1Mallinckrodt Pharmaceuticals
01 1PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE)
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2012-10-24
Pay. Date : 2012-12-04
DMF Number : 191
Submission : 1956-01-24
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 PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE), with a corresponding US DMF Number 191.
Remarkably, this DMF maintains an Active status since its submission on January 24, 1956, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 24, 2012, and payment made on December 04, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
