Details for New Drug Application (NDA): 090466
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The generic ingredient in GEMIFLOXACIN MESYLATE 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 090466
Tradename: | GEMIFLOXACIN MESYLATE |
Applicant: | Orbion Pharms |
Ingredient: | gemifloxacin mesylate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 320MG BASE | ||||
Approval Date: | Jun 15, 2015 | TE: | RLD: | No |
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