← FDA Drug Approvals (Drugs@FDA)
PITOLISANT
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MSN LABORATORIES PRIVATE LTD · Approved 2025-05-06
Drug application
- FDA Application #
ANDA218873- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PITOLISANT
- Generic name
- Pitolisant
- Active ingredients
- PITOLISANT
- Dosage form
- TABLET
- Route
- FILM COATED
- Marketing status
- None (Tentative Approval)
- Sponsor
- MSN LABORATORIES PRIVATE LTD
- First approval
- 2025-05-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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