01 1Hetero Drugs
01 1NAPROXEN SODIUM
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-12
Pay. Date : 2023-09-01
DMF Number : 38216
Submission : 2023-04-07
Status : Active
Type : II
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Hetero Labs 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 NAPROXEN SODIUM, with a corresponding US DMF Number 38216.
Remarkably, this DMF maintains an Active status since its submission on April 07, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 12, 2023, and payment made on September 01, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
