01 1Hetero Drugs
01 1FOSTAMATINIB DISODIUM HEXAHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-04
Pay. Date : 2022-01-05
DMF Number : 36629
Submission : 2022-02-04
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 FOSTAMATINIB DISODIUM HEXAHYDRATE, with a corresponding US DMF Number 36629.
Remarkably, this DMF maintains an Active status since its submission on February 04, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 04, 2022, and payment made on January 05, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
