01 1Kalintis Healthcare
01 1DIPHENOXYLATE HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-11-13
Pay. Date : 2025-09-24
DMF Number : 42698
Submission : 2025-09-30
Status : Active
Type : II
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Kalintis Healthcare Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is DIPHENOXYLATE HYDROCHLORIDE, with a corresponding US DMF Number 42698.
Remarkably, this DMF maintains an Active status since its submission on September 30, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 13, 2025, and payment made on September 24, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
