Details for New Drug Application (NDA): 021158
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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 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Apr 4, 2003 | TE: | 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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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