Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Medtronic
Farmers Insurance
Federal Trade Commission
Daiichi Sankyo
Mallinckrodt

Generated: July 20, 2019

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, Mylan, and Sandoz Inc, and is included in five NDAs. It is available from five 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 202653
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 57297-435-01 1 BOTTLE in 1 CARTON (57297-435-01) > 2.5 mL in 1 BOTTLE
GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 202653 ANDA Lupin Pharmaceuticals, Inc. 68180-435 68180-435-01 1 BOTTLE in 1 CARTON (68180-435-01) > 2.5 mL in 1 BOTTLE

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:

Teva
Johnson and Johnson
QuintilesIMS
Julphar
McKesson
McKinsey

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