01 1Hetero Drugs
01 1BUPROPION HYDROBROMIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-11-04
Pay. Date : 2024-10-21
DMF Number : 40583
Submission : 2024-10-18
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 BUPROPION HYDROBROMIDE, with a corresponding US DMF Number 40583.
Remarkably, this DMF maintains an Active status since its submission on October 18, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 04, 2024, and payment made on October 21, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
