01 1Hetero Drugs
01 1NEBIVOLOL HYDROCHLORIDE (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-16
Pay. Date : 2016-10-31
DMF Number : 31081
Submission : 2016-11-02
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 NEBIVOLOL HYDROCHLORIDE (PROCESS-II), with a corresponding US DMF Number 31081.
Remarkably, this DMF maintains an Active status since its submission on November 02, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 16, 2017, and payment made on October 31, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
