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Serving hundreds of leading biopharmaceutical companies globally:

UBS
McKinsey
Cerilliant
Colorcon
Mallinckrodt
Cipla
Medtronic
Dow
Queensland Health

Generated: June 18, 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, Micro Labs, 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. 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:

Cipla
Johnson and Johnson
Daiichi Sankyo
Julphar
Queensland Health
Mallinckrodt
Accenture
Boehringer Ingelheim
Medtronic

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