Vivlodex

NDA 207233, held by Iceutica Operations. Meloxicam.

As of Nov 13, 2026, NDA 207233 (Vivlodex), held by Iceutica Operations, was first approved by FDA on Oct 22, 2015, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 22, 2015
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Oct 22, 2015	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

2 strengths and forms

Product	Active ingredient	Marketing
Vivlodex5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Meloxicam	DiscontinuedReference drug
Vivlodex10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Meloxicam	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 21, 2024	Supplement 5Labeling · Standard review	Approved	Label Medication Guide Letter
Apr 28, 2021	Supplement 4Labeling · Standard review	Approved	Label Letter
May 17, 2016	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 22, 2015	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 207233
Drugs@FDA: Overview at FDA
Company: Iceutica Operations

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