01 1Formosa Laboratories
01 1GADOTERATE MEGLUMINE
01 1Taiwan
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-06
Pay. Date : 2019-09-26
DMF Number : 34129
Submission : 2019-09-12
Status : Active
Type : II
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Formosa Laboratories Inc, based in Taiwan, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is GADOTERATE MEGLUMINE, with a corresponding US DMF Number 34129.
Remarkably, this DMF maintains an Active status since its submission on September 12, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 06, 2019, and payment made on September 26, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
