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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
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