01 1Rolabo Outsourcing
01 1TETRABENAZINE
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-01-06
Pay. Date : 2015-10-06
DMF Number : 29828
Submission : 2015-10-09
Status : Active
Type : II
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Rolabo Outsourcing Sl, based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is TETRABENAZINE, with a corresponding US DMF Number 29828.
Remarkably, this DMF maintains an Active status since its submission on October 09, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 06, 2016, and payment made on October 06, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
