01 1Hetero Drugs
01 1DIVALPROEX SODIUM
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-27
Pay. Date : 2018-09-25
DMF Number : 31437
Submission : 2018-09-20
Status : Active
Type : II
20
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 DIVALPROEX SODIUM, with a corresponding US DMF Number 31437.
Remarkably, this DMF maintains an Active status since its submission on September 20, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 27, 2018, and payment made on September 25, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
