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Last Updated: August 12, 2020

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Details for New Drug Application (NDA): 206446

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NDA 206446 describes GATIFLOXACIN, which is a drug marketed by Apotex Inc, Hi-tech Pharma Co, Lupin Ltd, Mylan, and Sandoz Inc, and is included in five NDAs. It is available from four suppliers. Additional details are available on the GATIFLOXACIN profile page.

The generic ingredient in GATIFLOXACIN is gatifloxacin. There are sixteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the gatifloxacin profile page.
Summary for 206446
Tradename:GATIFLOXACIN
Applicant:Mylan
Ingredient:gatifloxacin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206446
Suppliers and Packaging for NDA: 206446
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 206446 ANDA Mylan Pharmaceuticals Inc. 0378-5431 0378-5431-35 1 BOTTLE in 1 CARTON (0378-5431-35) > 2.5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Jun 8, 2018TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

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