01 1Hetero Drugs
01 1DOLUTEGRAVIR SODIUM (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-21
Pay. Date : 2018-11-19
DMF Number : 32955
Submission : 2018-08-14
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 DOLUTEGRAVIR SODIUM (PROCESS-II), with a corresponding US DMF Number 32955.
Remarkably, this DMF maintains an Active status since its submission on August 14, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 21, 2018, and payment made on November 19, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
