← FDA DRUG APPROVALS

FDA NDA · NDA209310

SINUVA

mometasone furoate

Sponsor: INTERSECT ENT INC

APPLICATION
NDA209310
TYPE
NDA
ORIGINAL APPROVAL
2017-12-08
LATEST ACTION
2023-01-20
ROUTE
INTRASINAL, IMPLANTATION
DOSAGE FORM
IMPLANT
MARKETING STATUS
Prescription

Products

SINUVA · ReferencePrescription
MOMETASONE FUROATE 1.35MG · IMPLANT · IMPLANTATION

Approval history

2023-01-20Labeling · Supplement 6 · standard — Letter ↗AP
2020-04-28Efficacy · Supplement 3 · standard — Label ↗AP
2018-01-12Labeling · Supplement 1 · standard — Label ↗AP
2017-12-08Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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