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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 211525


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NDA 211525 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, Chartwell Rx, Dr Reddys Labs Ltd, Ranbaxy Labs Ltd, and Teva, and is included in twenty-eight NDAs. It is available from thirty 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-one suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.
Summary for 211525
Tradename:OFLOXACIN
Applicant:Amneal
Ingredient:ofloxacin
Patents:0
Pharmacology for NDA: 211525
Suppliers and Packaging for NDA: 211525
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OFLOXACIN ofloxacin SOLUTION/DROPS;OTIC 211525 ANDA A-S Medication Solutions 50090-5670 50090-5670-0 1 BOTTLE, DROPPER in 1 CARTON (50090-5670-0) / 5 mL in 1 BOTTLE, DROPPER
OFLOXACIN ofloxacin SOLUTION/DROPS;OTIC 211525 ANDA RedPharm Drug 67296-1819 67296-1819-5 5 mL in 1 CARTON (67296-1819-5)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OTICStrength0.3%
Approval Date:Aug 30, 2019TE:ATRLD:No

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