01 1Hetero Drugs
01 1LENVATINIB MESYLATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-05-12
Pay. Date : 2025-04-11
DMF Number : 39887
Submission : 2024-04-30
Status : Active
Type : II
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Hetero Labs Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is LENVATINIB MESYLATE, with a corresponding US DMF Number 39887.
Remarkably, this DMF maintains an Active status since its submission on April 30, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 12, 2025, and payment made on April 11, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
