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Dyloject Approval History

FDA Approved: Yes (Discontinued) (First approved December 23, 2014)
Brand name: Dyloject
Generic name: diclofenac sodium
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: Pain

Marketing Status: Discontinued

Dyloject (diclofenac sodium injection) is an intravenous non-steroidal anti-inflammatory drug (NSAID) for the management of acute moderate-to-severe pain in adults.

Development History and FDA Approval Process for Dyloject

DateArticle
Dec 30, 2014Approval Hospira Receives U.S. FDA Approval of Proprietary Analgesic Dyloject (diclofenac sodium) Injection
Feb 17, 2010Javelin Pharmaceuticals' Receives FDA PDUFA Date for Dyloject NDA
Feb  2, 2010FDA Accepts Javelin Pharmaceuticals' Dyloject New Drug Application for Formal Review
Dec  2, 2009Javelin Pharmaceuticals Submits Dyloject New Drug Application to FDA for Management of Acute Moderate-to-Severe Pain in Adults

Further information

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