01 1ADL BioPharma
01 1AMOXICILLIN TRIHYDRATE
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-02
Pay. Date : 2016-10-14
DMF Number : 30725
Submission : 2016-07-06
Status : Active
Type : II
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Antibioticos De Leon Slu, based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is AMOXICILLIN TRIHYDRATE, with a corresponding US DMF Number 30725.
Remarkably, this DMF maintains an Active status since its submission on July 06, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 02, 2017, and payment made on October 14, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
