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FDA NDA · NDA209575

NUMBRINO

cocaine hydrochloride nasal

Sponsor: OMNIVIUM PHARMS

APPLICATION
NDA209575
TYPE
NDA
ORIGINAL APPROVAL
2020-01-10
LATEST ACTION
2020-08-27
ROUTE
TOPICAL, NASAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

NUMBRINO · ReferencePrescription
COCAINE HYDROCHLORIDE 4% · SOLUTION · NASAL

Approval history

2020-08-27Labeling · Supplement 2 · standard — Letter ↗AP
2020-01-10Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Letter ↗AP
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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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