← FDA Drug Approvals (Drugs@FDA)
NALOXONE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2024-04-23
Drug application
- FDA Application #
ANDA217992
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- NALOXONE HYDROCHLORIDE
- Generic name
- NALOXONE
- Active ingredients
- NALOXONE HYDROCHLORIDE
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Marketing status
- Over-the-counter
- Sponsor
- AMNEAL
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- First approval
- 2024-04-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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