01 1Hetero Drugs
01 1MIRTAZAPINE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-27
Pay. Date : 2024-01-23
DMF Number : 38341
Submission : 2023-05-15
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 MIRTAZAPINE, with a corresponding US DMF Number 38341.
Remarkably, this DMF maintains an Active status since its submission on May 15, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 27, 2024, and payment made on January 23, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
