01 1Hetero Drugs
01 1RIVAROXABAN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-04-10
Pay. Date : 2023-02-24
DMF Number : 38061
Submission : 2023-02-23
Status : Active
Type : II
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Hetero Drugs 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 RIVAROXABAN, with a corresponding US DMF Number 38061.
Remarkably, this DMF maintains an Active status since its submission on February 23, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 10, 2023, and payment made on February 24, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
