01 1Hetero Drugs
01 1TETRABENAZINE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-16
Pay. Date : 2013-05-23
DMF Number : 26113
Submission : 2012-06-04
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 TETRABENAZINE, with a corresponding US DMF Number 26113.
Remarkably, this DMF maintains an Active status since its submission on June 04, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 16, 2013, and payment made on May 23, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
