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Last Updated: September 29, 2020

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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 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

Profile for product number 001

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

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

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