Details for New Drug Application (NDA): 022396

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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-eight 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		Strength	37.5MG/ML (37.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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:	⤷ Sign Up	Patent Expiration:	Mar 22, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF PAIN

Expired US Patents for NDA 022396

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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	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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