01 1Teva Pharmaceutical Industries
01 1ELAGOLIX SODIUM
01 1Israel
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-02-28
Pay. Date : 2021-12-13
DMF Number : 36570
Submission : 2022-02-08
Status : Active
Type : II
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Tapi Nl Bv, based in Israel, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is ELAGOLIX SODIUM, with a corresponding US DMF Number 36570.
Remarkably, this DMF maintains an Active status since its submission on February 08, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 28, 2022, and payment made on December 13, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
