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FDA ANDA · ANDA211951

NALOXONE HYDROCHLORIDE

Sponsor: PADAGIS ISRAEL

APPLICATION
ANDA211951
TYPE
ANDA
ORIGINAL APPROVAL
2022-06-21
LATEST ACTION
2023-07-18
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Over-the-counter

Products

NALOXONE HYDROCHLORIDEOver-the-counter
NALOXONE HYDROCHLORIDE 4MG/SPRAY · SPRAY, METERED · NASAL

Approval history

2023-07-18Labeling · Supplement 3 · standardLetterAP
2022-06-21UNKNOWN · Original · standardLetterAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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