01 1Hetero Drugs
01 1VORICONAZOLE (FORM-I)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-09
Pay. Date : 2017-10-13
DMF Number : 32138
Submission : 2017-11-14
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 VORICONAZOLE (FORM-I), with a corresponding US DMF Number 32138.
Remarkably, this DMF maintains an Active status since its submission on November 14, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 09, 2018, and payment made on October 13, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
