01 1Sumitomo Chemical
01 1HYDRALAZINE HYDROCHLORIDE
01 1Japan
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-20
Pay. Date : 2023-09-15
DMF Number : 2421
Submission : 1975-03-14
Status : Active
Type : II
20
Sumitomo Chemical Co Ltd, based in Japan, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is HYDRALAZINE HYDROCHLORIDE, with a corresponding US DMF Number 2421.
Remarkably, this DMF maintains an Active status since its submission on March 14, 1975, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 20, 2023, and payment made on September 15, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
