01 1Esteve Quimica
01 1LEVETIRACETAM INJECTABLE GRADE/NON-STERILE
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-19
Pay. Date : 2016-12-23
DMF Number : 21837
Submission : 2008-07-28
Status : Active
Type : II
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Esteve Quimica Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is LEVETIRACETAM INJECTABLE GRADE/NON-STERILE, with a corresponding US DMF Number 21837.
Remarkably, this DMF maintains an Active status since its submission on July 28, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 19, 2017, and payment made on December 23, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
