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Details for New Drug Application (NDA): 021504

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NDA 021504 describes LIDOSITE TOPICAL SYSTEM KIT, which is a drug marketed by Vyteris and is included in one NDA. There are two patents protecting this drug. 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 seventeen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.

Summary for NDA: 021504

Tradename:
LIDOSITE TOPICAL SYSTEM KIT
Applicant:
Vyteris
Ingredient:
epinephrine; lidocaine hydrochloride
Patents:2
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:PATCH;IONTOPHORESIS, TOPICALStrength1.05MG/PATCH;100MG/PATCH
Approval Date:May 6, 2004TE:RLD:No
Patent:6,629,968Patent Expiration:Jun 30, 2020Product Flag?YSubstance Flag?YDelist Request?
Patent:6,635,045Patent Expiration:Jun 29, 2021Product Flag?YSubstance Flag?YDelist Request?

Expired Orange Book 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, TOPICAL021504-001May 6, 20045,246,418► subscribe
Vyteris
LIDOSITE TOPICAL SYSTEM KIT
epinephrine; lidocaine hydrochloride
PATCH;IONTOPHORESIS, TOPICAL021504-001May 6, 20046,862,473► subscribe
Vyteris
LIDOSITE TOPICAL SYSTEM KIT
epinephrine; lidocaine hydrochloride
PATCH;IONTOPHORESIS, TOPICAL021504-001May 6, 20046,385,488► subscribe
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