01 1Quimica Sintetica
01 1FLUOXETINE HYDROCHLORIDE
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-05-27
Pay. Date : 2021-03-03
DMF Number : 12291
Submission : 1996-12-18
Status : Active
Type : II
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Quimica Sintetica Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from EDQM.
One of their notable products is FLUOXETINE HYDROCHLORIDE, with a corresponding US DMF Number 12291.
Remarkably, this DMF maintains an Active status since its submission on December 18, 1996, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 27, 2021, and payment made on March 03, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
