01 1Symed Labs
01 1SERTRALINE HYDROCHLORIDE (FORM-I) USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-12
Pay. Date : 2024-01-09
DMF Number : 38163
Submission : 2023-03-16
Status : Active
Type : II
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Symed Labs Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is SERTRALINE HYDROCHLORIDE (FORM-I) USP, with a corresponding US DMF Number 38163.
Remarkably, this DMF maintains an Active status since its submission on March 16, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 12, 2024, and payment made on January 09, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
