01 1Synthon Pharmaceuticals
01 1OZANIMOD HYDROCHLORIDE
01 1Netherlands
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-22
Pay. Date : 2023-11-17
DMF Number : 38668
Submission : 2023-11-23
Status : Active
Type : II
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Synthon Bv, based in Netherlands, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is OZANIMOD HYDROCHLORIDE, with a corresponding US DMF Number 38668.
Remarkably, this DMF maintains an Active status since its submission on November 23, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 22, 2024, and payment made on November 17, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
