01 1FDC
01 1BRIMONIDINE TARTRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-09-16
Pay. Date : 2025-08-18
DMF Number : 20855
Submission : 2007-09-17
Status : Active
Type : II
20
Fdc 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 BRIMONIDINE TARTRATE USP, with a corresponding US DMF Number 20855.
Remarkably, this DMF maintains an Active status since its submission on September 17, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 16, 2025, and payment made on August 18, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
