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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Express Scripts
McKinsey
Julphar
US Army
Chubb
Teva
Colorcon
UBS

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202653

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NDA 202653 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 202653
Tradename:GATIFLOXACIN
Applicant:Lupin Ltd
Ingredient:gatifloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 202653
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 202653
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 202653 ANDA LUPIN LIMITED 57297-435 E 57297-435-01
GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 202653 ANDA Lupin Pharmaceuticals, Inc. 68180-435 N 68180-435-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Aug 28, 2013TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Merck
US Department of Justice
Farmers Insurance
Julphar
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Mallinckrodt
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