01 1Hikma Pharmaceuticals
01 1ONDANSETRON HYDROCHLORIDE, USP
01 1United Kingdom
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-12-21
Pay. Date : 2022-12-19
DMF Number : 22181
Submission : 2008-11-13
Status : Active
Type : II
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Hikma Pharmaceuticals, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is ONDANSETRON HYDROCHLORIDE, USP, with a corresponding US DMF Number 22181.
Remarkably, this DMF maintains an Active status since its submission on November 13, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 21, 2022, and payment made on December 19, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
