01 1Wanbury Limited
01 1SERTRALINE HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-07-20
Pay. Date : 2020-07-08
DMF Number : 19035
Submission : 2005-12-13
Status : Active
Type : II
20
Wanbury 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 SERTRALINE HYDROCHLORIDE, with a corresponding US DMF Number 19035.
Remarkably, this DMF maintains an Active status since its submission on December 13, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 20, 2020, and payment made on July 08, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
