01 1UQUIFA
01 1CYCLOPENTOLATE HYDROCHLORIDE
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-31
Pay. Date : 2013-07-26
DMF Number : 7272
Submission : 1987-12-31
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 CYCLOPENTOLATE HYDROCHLORIDE, with a corresponding US DMF Number 7272.
Remarkably, this DMF maintains an Active status since its submission on December 31, 1987, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 31, 2013, and payment made on July 26, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
