01 1Kalintis Healthcare
01 1MEXILETINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-01
Pay. Date : 2020-09-21
DMF Number : 35146
Submission : 2020-09-23
Status : Active
Type : II
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Kalintis Healthcare Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is MEXILETINE HYDROCHLORIDE USP, with a corresponding US DMF Number 35146.
Remarkably, this DMF maintains an Active status since its submission on September 23, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 01, 2020, and payment made on September 21, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
