01 1Hetero Drugs
01 1ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-14
Pay. Date : 2016-05-24
DMF Number : 28357
Submission : 2014-06-05
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 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, with a corresponding US DMF Number 28357.
Remarkably, this DMF maintains an Active status since its submission on June 05, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 14, 2016, and payment made on May 24, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
