01 1Hetero Drugs
01 1EZETIMIBE (FORM-B)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-04
Pay. Date : 2016-05-03
DMF Number : 29882
Submission : 2015-10-05
Status : Active
Type : II
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Hetero Labs 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 EZETIMIBE (FORM-B), with a corresponding US DMF Number 29882.
Remarkably, this DMF maintains an Active status since its submission on October 05, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 04, 2016, and payment made on May 03, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
