01 1Aurobindo Pharma Limited
01 1ONDANSETRON HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-08
Pay. Date : 2015-01-02
DMF Number : 19071
Submission : 2005-12-19
Status : Active
Type : II
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Apitoria Pharma Private 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 ONDANSETRON HYDROCHLORIDE USP, with a corresponding US DMF Number 19071.
Remarkably, this DMF maintains an Active status since its submission on December 19, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 08, 2015, and payment made on January 02, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
