01 1Hetero Drugs
01 1FAMOTIDINE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-09
Pay. Date : 2021-03-17
DMF Number : 35678
Submission : 2021-04-30
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 FAMOTIDINE, with a corresponding US DMF Number 35678.
Remarkably, this DMF maintains an Active status since its submission on April 30, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 09, 2021, and payment made on March 17, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
