01 1Hetero Drugs
01 1ROFLUMILAST
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-17
Pay. Date : 2014-08-14
DMF Number : 28516
Submission : 2014-08-27
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 ROFLUMILAST, with a corresponding US DMF Number 28516.
Remarkably, this DMF maintains an Active status since its submission on August 27, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 17, 2014, and payment made on August 14, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
