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FDA NDA · NDA209963

COCAINE HYDROCHLORIDE

Sponsor: LXO IRELAND

APPLICATION
NDA209963
TYPE
NDA
ORIGINAL APPROVAL
2017-12-14
LATEST ACTION
2023-07-18
ROUTE
NASAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

GOPRELTO · ReferencePrescription
COCAINE HYDROCHLORIDE 4% · SOLUTION · NASAL

Approval history

2023-07-18Labeling · Supplement 5 · standard — Letter ↗AP
2022-11-28Labeling · Supplement 4 · standard — Letter ↗AP
2017-12-14Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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