01 1Rolabo Outsourcing
01 1LORATADINE USP
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-26
Pay. Date : 2014-07-02
DMF Number : 14155
Submission : 1999-05-26
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 LORATADINE USP, with a corresponding US DMF Number 14155.
Remarkably, this DMF maintains an Active status since its submission on May 26, 1999, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 26, 2015, and payment made on July 02, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
