01 1Ipca Laboratories
01 1ONDANSETRON HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-04
Pay. Date : 2013-08-21
DMF Number : 20771
Submission : 2007-08-20
Status : Active
Type : II
20
Ipca Laboratories 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 20771.
Remarkably, this DMF maintains an Active status since its submission on August 20, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 04, 2013, and payment made on August 21, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
