← FDA Drug Approvals (Drugs@FDA)
LEGUBETI
NDA · New Drug Application · Sponsor: GALEPHAR · Approved 2024-02-13
Drug application
- FDA Application #
NDA215040
- Application type
- New Drug Application
- Brand name
- LEGUBETI
- Generic name
- Acetylcysteine Lysine
- Active ingredients
- ACETYLCYSTEINE LYSINE
- Dosage form
- FOR SOLUTION
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- GALEPHAR
- First approval
- 2024-02-13
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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