01 1FDC
01 1OLOPATADINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-28
Pay. Date : 2015-09-21
DMF Number : 29464
Submission : 2015-06-23
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 OLOPATADINE HYDROCHLORIDE USP, with a corresponding US DMF Number 29464.
Remarkably, this DMF maintains an Active status since its submission on June 23, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 28, 2016, and payment made on September 21, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
