01 1Hetero Drugs
01 1IVABRADINE HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-04
Pay. Date : 2018-12-04
DMF Number : 33368
Submission : 2018-12-12
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 IVABRADINE HYDROCHLORIDE, with a corresponding US DMF Number 33368.
Remarkably, this DMF maintains an Active status since its submission on December 12, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 04, 2019, and payment made on December 04, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
