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Last Updated: July 21, 2024

Details for New Drug Application (NDA): 021158


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NDA 021158 describes FACTIVE, which is a drug marketed by Lg Chem Ltd and is included in one NDA. Additional details are available on the FACTIVE profile page.

The generic ingredient in FACTIVE is gemifloxacin mesylate. There are two drug master file entries for this compound. Additional details are available on the gemifloxacin mesylate profile page.
Summary for 021158
Tradename:FACTIVE
Applicant:Lg Chem Ltd
Ingredient:gemifloxacin mesylate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Apr 4, 2003TE:RLD:Yes

Expired US Patents for NDA 021158

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 ⤷  Sign Up ⤷  Sign Up
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 ⤷  Sign Up ⤷  Sign Up
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 ⤷  Sign Up ⤷  Sign Up
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 ⤷  Sign Up ⤷  Sign Up
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 ⤷  Sign Up ⤷  Sign Up
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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