Otiprio

NDA 207986, held by Alk Abello. Ciprofloxacin.

As of Nov 13, 2026, NDA 207986 (Otiprio), held by Alk Abello, was first approved by FDA on Dec 10, 2015, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 10, 2015
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below


Mar 2, 2018	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 10, 2015	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Otiprio6% (60MG/ML) · injectable, suspension;otic	Ciprofloxacin	DiscontinuedReference drug

All 3 submissions, including labeling and manufacturing supplements


Mar 2, 2018	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 27, 2016	Supplement 1Labeling · Standard review	Approved	Label Letter
Dec 10, 2015	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 207986
Drugs@FDA: Overview at FDA
Company: ALK-Abelló

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters