01 1Daewoong Pharmaceutical
01 1URSODIOL USP (PROCESS I)
01 1South Korea
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-08
Pay. Date : 2014-12-23
DMF Number : 25536
Submission : 2011-11-16
Status : Active
Type : II
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Daewoong Bio Inc, based in South Korea, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is URSODIOL USP (PROCESS I), with a corresponding US DMF Number 25536.
Remarkably, this DMF maintains an Active status since its submission on November 16, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 08, 2016, and payment made on December 23, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
