01 1SMS Pharmaceuticals
01 1LAMOTRIGINE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-24
Pay. Date : 2023-09-26
DMF Number : 34290
Submission : 2019-11-20
Status : Active
Type : II
20
Sms Pharmaceuticals 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 LAMOTRIGINE USP, with a corresponding US DMF Number 34290.
Remarkably, this DMF maintains an Active status since its submission on November 20, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 24, 2023, and payment made on September 26, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
