01 1Hetero Drugs
01 1ELAGOLIX SODIUM
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-01
Pay. Date : 2022-05-02
DMF Number : 37037
Submission : 2022-05-07
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 ELAGOLIX SODIUM, with a corresponding US DMF Number 37037.
Remarkably, this DMF maintains an Active status since its submission on May 07, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 01, 2022, and payment made on May 02, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
