Details for New Drug Application (NDA): 021504

NDA 021504 describes LIDOSITE TOPICAL SYSTEM KIT, which is a drug marketed by Vyteris and is included in one NDA. Additional details are available on the LIDOSITE TOPICAL SYSTEM KIT profile page.

The generic ingredient in LIDOSITE TOPICAL SYSTEM KIT is epinephrine; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.

Summary for 021504

Tradename:	LIDOSITE TOPICAL SYSTEM KIT
Applicant:	Vyteris
Ingredient:	epinephrine; lidocaine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	PATCH;IONTOPHORESIS, TOPICAL			Strength	1.05MG/PATCH;100MG/PATCH
Approval Date:	May 6, 2004	TE:		RLD:	No

Expired US Patents for NDA 021504

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004

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