Dyloject

NDA 22396, held by Javelin Pharms Inc. Diclofenac Sodium.

As of Nov 13, 2026, NDA 22396 (Dyloject), held by Javelin Pharms Inc, was first approved by FDA on Dec 23, 2014, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 23, 2014
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
Dec 23, 2014	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dyloject37.5MG/ML (37.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;intravenous	Diclofenac Sodium	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 9, 2016	Supplement 3Labeling · Standard review	Approved	Label Letter
Jul 15, 2015	Supplement 1Manufacturing · Standard review	Approved	None posted
May 27, 2015	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 23, 2014	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 22396
Drugs@FDA: Overview at FDA
Company: Javelin Pharmaceuticals

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