Details for New Drug Application (NDA): 218495
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NDA 218495 describes PITOLISANT HYDROCHLORIDE, which is a drug marketed by Novitium Pharma and is included in one NDA. Additional details are available on the PITOLISANT HYDROCHLORIDE profile page.
The generic ingredient in PITOLISANT HYDROCHLORIDE is pitolisant hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pitolisant hydrochloride profile page.
The generic ingredient in PITOLISANT HYDROCHLORIDE is pitolisant hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pitolisant hydrochloride profile page.
Summary for 218495
| Tradename: | PITOLISANT HYDROCHLORIDE |
| Applicant: | Novitium Pharma |
| Ingredient: | pitolisant hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4.45MG BASE | ||||
| Approval Date: | Jul 21, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 17.8MG BASE | ||||
| Approval Date: | Jul 21, 2026 | TE: | AB | RLD: | No | ||||
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