01 1Sun Pharmaceutical Industries Limited
01 1ELAGOLIX SODIUM
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-07-08
Pay. Date : 2022-07-05
DMF Number : 36344
Submission : 2022-05-11
Status : Active
Type : II
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Sun Pharmaceutical Industries 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 36344.
Remarkably, this DMF maintains an Active status since its submission on May 11, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 08, 2022, and payment made on July 05, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
