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Serving leading biopharmaceutical companies globally:

Cipla
Cerilliant
Argus Health
Fuji
Baxter
Merck
Moodys
McKesson
Express Scripts
Covington

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203189

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NDA 203189 describes GATIFLOXACIN, which is a drug marketed by Apotex Inc, Hi-tech Pharma Co, Lupin Ltd, and Sandoz Inc, and is included in four 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. Seven suppliers are listed for this compound. Additional details are available on the gatifloxacin profile page.
Summary for 203189
Tradename:GATIFLOXACIN
Applicant:Hi-tech Pharma Co
Ingredient:gatifloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 203189
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 203189
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 203189 ANDA Hi-Tech Pharmacal Co., Inc. 50383-189 N 50383-189-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Sep 3, 2014TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Queensland Health
Mallinckrodt
Merck
Colorcon
Moodys
McKesson
McKinsey
Cerilliant

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