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FDA NDA · NDA207986

OTIPRIO

Sponsor: ALK ABELLO

APPLICATION
NDA207986
TYPE
NDA
ORIGINAL APPROVAL
2015-12-10
LATEST ACTION
2018-03-02
ROUTE
OTIC
DOSAGE FORM
INJECTABLE, SUSPENSION
MARKETING STATUS
Discontinued

Products

OTIPRIO · ReferenceDiscontinued
CIPROFLOXACIN 6% (60MG/ML) · INJECTABLE, SUSPENSION · OTIC

Approval history

2018-03-02Efficacy · Supplement 2 · standard — Label ↗AP
2016-01-27Labeling · Supplement 1 · standard — Label ↗AP
2015-12-10Type 5 - New Formulation or New Manufacturer · 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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