01 1Hetero Drugs
01 1LEVETIRACETAM (FORM-1), PROCESS-II
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-30
Pay. Date : 2016-06-28
DMF Number : 30626
Submission : 2016-06-27
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 LEVETIRACETAM (FORM-1), PROCESS-II, with a corresponding US DMF Number 30626.
Remarkably, this DMF maintains an Active status since its submission on June 27, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 30, 2016, and payment made on June 28, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
