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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 077098


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NDA 077098 describes OFLOXACIN, which is a drug marketed by Bedford, Altaire Pharms Inc, Alvogen, Amneal, Apotex Inc, Bausch And Lomb, Caplin, Epic Pharma Llc, Fdc Ltd, Mankind Pharma, Sandoz, Sentiss, Somerset, Hikma, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Larken Labs, Ranbaxy Labs Ltd, and Teva, and is included in twenty-eight NDAs. It is available from twenty-nine 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. Thirty suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.
Summary for 077098
Tradename:OFLOXACIN
Applicant:Dr Reddys Labs Ltd
Ingredient:ofloxacin
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Feb 10, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Feb 10, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Feb 10, 2006TE:ABRLD:No

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