Details for New Drug Application (NDA): 218846
NDA 218846 describes PITOLISANT HYDROCHLORIDE, which is a drug marketed by Lupin, MSN, and Novitium Pharma, and is included in three NDAs. It is available from one supplier. 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. Two suppliers are 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. Two suppliers are listed for this compound. Additional details are available on the pitolisant hydrochloride profile page.
Summary for 218846
| Tradename: | PITOLISANT HYDROCHLORIDE |
| Applicant: | Lupin |
| Ingredient: | pitolisant hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218846
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PITOLISANT HYDROCHLORIDE | pitolisant hydrochloride | TABLET;ORAL | 218846 | ANDA | Lupin Pharmaceuticals, Inc. | 70748-386 | 70748-386-01 | 1 BOTTLE in 1 CARTON (70748-386-01) / 30 TABLET, FILM COATED in 1 BOTTLE |
| PITOLISANT HYDROCHLORIDE | pitolisant hydrochloride | TABLET;ORAL | 218846 | ANDA | Lupin Pharmaceuticals, Inc. | 70748-387 | 70748-387-01 | 1 BOTTLE in 1 CARTON (70748-387-01) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4.45MG BASE | ||||
| Approval Date: | Aug 14, 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: | Aug 14, 2026 | TE: | AB | RLD: | No | ||||
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