01 1Hetero Drugs
01 1ISOTRETINOIN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-18
Pay. Date : 2022-03-15
DMF Number : 36857
Submission : 2022-03-22
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 ISOTRETINOIN, with a corresponding US DMF Number 36857.
Remarkably, this DMF maintains an Active status since its submission on March 22, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 18, 2022, and payment made on March 15, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
