FdaApplication
ANDA 218495
Identifiers
- fda_app_no: ANDA218495
Properties
| Property | Value |
|---|---|
| applicant_name | NOVITIUM PHARMA LLC |
| application_type | ANDA |
| approval_date | 2026-07-21 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PITOLISANT HYDROCHLORIDE | PITOLISANT HYDROCHLORIDE | EQ 17.8MG BASE | TABLET;ORAL |
| PITOLISANT HYDROCHLORIDE | PITOLISANT HYDROCHLORIDE | EQ 4.45MG BASE | TABLET;ORAL |
2 products