01 1Natco Pharma
01 1ONDANSETRON HYDROCHLORIDE (INJECTABLE GRADE)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-14
Pay. Date : 2014-01-08
DMF Number : 20675
Submission : 2007-07-12
Status : Active
Type : II
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Natco Pharma 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 (INJECTABLE GRADE), with a corresponding US DMF Number 20675.
Remarkably, this DMF maintains an Active status since its submission on July 12, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 14, 2014, and payment made on January 08, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
