01 1Apicore
01 1LURBINECTEDIN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-28
Pay. Date : 2024-01-16
DMF Number : 39171
Submission : 2024-01-13
Status : Active
Type : II
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Apicore Llc, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is LURBINECTEDIN, with a corresponding US DMF Number 39171.
Remarkably, this DMF maintains an Active status since its submission on January 13, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 28, 2024, and payment made on January 16, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
