01 1Daewoong Pharmaceutical
01 1URSODIOL USP (PROCESS IV)
01 1South Korea
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-07-10
Pay. Date : 2015-02-02
DMF Number : 28994
Submission : 2015-02-10
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 IV), with a corresponding US DMF Number 28994.
Remarkably, this DMF maintains an Active status since its submission on February 10, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 10, 2015, and payment made on February 02, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
