01 1Biocon
01 1DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-19
Pay. Date : 2021-06-29
DMF Number : 35928
Submission : 2021-07-05
Status : Active
Type : II
20
Biocon Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE, with a corresponding US DMF Number 35928.
Remarkably, this DMF maintains an Active status since its submission on July 05, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 19, 2021, and payment made on June 29, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
