01 1Hetero Drugs
01 1MEXILETINE HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-19
Pay. Date : 2021-06-02
DMF Number : 35983
Submission : 2021-06-04
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 MEXILETINE HYDROCHLORIDE, with a corresponding US DMF Number 35983.
Remarkably, this DMF maintains an Active status since its submission on June 04, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 19, 2021, and payment made on June 02, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
