01 1Hetero Drugs
01 1DEXLANSOPRAZOLE SESQUIHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-12-15
Pay. Date : 2022-11-15
DMF Number : 37606
Submission : 2022-11-25
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 DEXLANSOPRAZOLE SESQUIHYDRATE, with a corresponding US DMF Number 37606.
Remarkably, this DMF maintains an Active status since its submission on November 25, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 15, 2022, and payment made on November 15, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
