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Last Updated: August 3, 2021

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Details for New Drug Application (NDA): 091656


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NDA 091656 describes OFLOXACIN, which is a drug marketed by Bedford, Akorn, Altaire Pharms Inc, Alvogen, Apotex Inc, Bausch And Lomb, Fdc Ltd, Sandoz, Sandoz Inc, Amneal, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Larken Labs, Ranbaxy Labs Ltd, and Teva, and is included in twenty-one NDAs. It is available from twenty suppliers. Additional details are available on the OFLOXACIN profile page.

The generic ingredient in OFLOXACIN is ofloxacin. There are seventy-eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.
Summary for 091656
Tradename:OFLOXACIN
Applicant:Cadila Pharms Ltd
Ingredient:ofloxacin
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 18, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Sep 18, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Sep 18, 2014TE:ABRLD:No

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