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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 211524


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NDA 211524 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 211524
Tradename:OFLOXACIN
Applicant:Amneal
Ingredient:ofloxacin
Patents:0
Pharmacology for NDA: 211524
Suppliers and Packaging for NDA: 211524
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 211524 ANDA Amneal Pharmaceuticals NY LLC 69238-1665 69238-1665-6 1 BOTTLE, DROPPER in 1 CARTON (69238-1665-6) / 10 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.3%
Approval Date:Mar 1, 2024TE:ATRLD:No

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