01 1Hikma Pharmaceuticals
01 1SOLRIAMFETOL HYDROCHLORIDE
01 1United Kingdom
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-04-04
Pay. Date : 2022-12-19
DMF Number : 37548
Submission : 2022-12-28
Status : Active
Type : II
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Hikma Pharmaceuticals Llc, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is SOLRIAMFETOL HYDROCHLORIDE, with a corresponding US DMF Number 37548.
Remarkably, this DMF maintains an Active status since its submission on December 28, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 04, 2023, and payment made on December 19, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
