01 1Viatris
01 1FOMEPIZOLE
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-08
Pay. Date : 2012-12-18
DMF Number : 19472
Submission : 2006-05-24
Status : Active
Type : II
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Mylan Pharmaceuticals Inc A Viatris Co, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is FOMEPIZOLE, with a corresponding US DMF Number 19472.
Remarkably, this DMF maintains an Active status since its submission on May 24, 2006, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 08, 2013, and payment made on December 18, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
