01 1Dasami Lab
01 1PITOLISANT HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-22
Pay. Date : 2023-04-21
DMF Number : 38307
Submission : 2023-05-09
Status : Active
Type : II
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Dasami Lab Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is PITOLISANT HYDROCHLORIDE, with a corresponding US DMF Number 38307.
Remarkably, this DMF maintains an Active status since its submission on May 09, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 22, 2023, and payment made on April 21, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
