01 1Hetero Drugs
01 1SOLRIAMFETOL HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-16
Pay. Date : 2023-04-12
DMF Number : 38280
Submission : 2023-04-18
Status : Active
Type : II
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Hetero Drugs 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 SOLRIAMFETOL HYDROCHLORIDE, with a corresponding US DMF Number 38280.
Remarkably, this DMF maintains an Active status since its submission on April 18, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 16, 2023, and payment made on April 12, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
