Details for New Drug Application (NDA): 022396

✉ Email this page to a colleague

NDA 022396 describes DYLOJECT, which is a drug marketed by Javelin Pharms Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the DYLOJECT profile page.

The generic ingredient in DYLOJECT is diclofenac sodium. There are forty-seven drug master file entries for this compound. One hundred and twenty-seven suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.

Summary for 022396

Tradename:	DYLOJECT
Applicant:	Javelin Pharms Inc
Ingredient:	diclofenac sodium
Patents:	1

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	37.5MG/ML (37.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 23, 2014	TE:		RLD:	Yes
Patent:	8,946,292	Patent Expiration:	Mar 22, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF PAIN

Expired US Patents for NDA 022396

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Javelin Pharms Inc	DYLOJECT	diclofenac sodium	SOLUTION;INTRAVENOUS	022396-001	Dec 23, 2014	6,407,079	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.