01 1Kalintis Healthcare
01 1BENZTROPINE MESYLATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-21
Pay. Date : 2020-07-29
DMF Number : 34964
Submission : 2020-07-29
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 BENZTROPINE MESYLATE USP, with a corresponding US DMF Number 34964.
Remarkably, this DMF maintains an Active status since its submission on July 29, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 21, 2020, and payment made on July 29, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
