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FDA NDA · NDA022408

NATROBA

spinosad

Sponsor: CIPHER

APPLICATION
NDA022408
TYPE
NDA
ORIGINAL APPROVAL
2011-01-18
LATEST ACTION
2021-04-28
ROUTE
TOPICAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

NATROBA · ReferencePrescription
SPINOSAD 0.9% · SUSPENSION · TOPICAL

Approval history

2021-04-28Efficacy · Supplement 10 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 8 · standard — Pediatric Other ↗AP
2014-12-30Efficacy · Supplement 5 · standard — Label ↗AP
2011-01-18Type 1 - New Molecular Entity · Original · standard — Review ↗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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