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Generated: August 21, 2018

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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 nineteen drug master file entries for this compound. Ten 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:2
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021504
Generic Entry Date for 021504*:
Constraining patent/regulatory exclusivity:
Dosage:
PATCH;IONTOPHORESIS, TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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:➤ Try a Free TrialPatent Expiration:Jun 30, 2020Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Try a Free 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 ➤ Try a Free Trial ➤ Try a Free Trial
Vyteris LIDOSITE TOPICAL SYSTEM KIT epinephrine; lidocaine hydrochloride PATCH;IONTOPHORESIS, TOPICAL 021504-001 May 6, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Vyteris LIDOSITE TOPICAL SYSTEM KIT epinephrine; lidocaine hydrochloride PATCH;IONTOPHORESIS, TOPICAL 021504-001 May 6, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Vyteris LIDOSITE TOPICAL SYSTEM KIT epinephrine; lidocaine hydrochloride PATCH;IONTOPHORESIS, TOPICAL 021504-001 May 6, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Vyteris LIDOSITE TOPICAL SYSTEM KIT epinephrine; lidocaine hydrochloride PATCH;IONTOPHORESIS, TOPICAL 021504-001 May 6, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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