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:

Chinese Patent Office
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Mallinckrodt
Boehringer Ingelheim
Citi
Daiichi Sankyo

Generated: July 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204227

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NDA 204227 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 204227
Tradename:GATIFLOXACIN
Applicant:Sandoz Inc
Ingredient:gatifloxacin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204227
Suppliers and Packaging for NDA: 204227
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 204227 ANDA Sandoz Inc 61314-672 61314-672-25 1 BOTTLE, DROPPER in 1 CARTON (61314-672-25) > 2.5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Jul 11, 2016TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
AstraZeneca
Julphar
Fish and Richardson
Chinese Patent Office
Healthtrust

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