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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
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Serving leading biopharmaceutical companies globally:

UBS
Argus Health
Colorcon
US Department of Justice
McKesson
Cerilliant
Deloitte
US Army
Fuji
Express Scripts

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021918

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NDA 021918 describes CETRAXAL, which is a drug marketed by Wraser Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the CETRAXAL profile page.

The generic ingredient in CETRAXAL is ciprofloxacin hydrochloride. There are thirty-one drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.

Summary for 021918

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 021918

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 021918

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETRAXAL ciprofloxacin hydrochloride SOLUTION/DROPS;OTIC 021918 NDA Xspire Pharma 42195-550 42195-550-14 14 CONTAINER in 1 CARTON (42195-550-14) > .25 mL in 1 CONTAINER
CETRAXAL ciprofloxacin hydrochloride SOLUTION/DROPS;OTIC 021918 NDA Wraser Llc 66992-450 66992-450-14 14 CONTAINER in 1 CARTON (66992-450-14) > .25 mL in 1 CONTAINER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OTICStrengthEQ 0.2% BASE
Approval Date:May 1, 2009TE:RLD:Yes


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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Federal Trade Commission
Cantor Fitzgerald
US Department of Justice
Boehringer Ingelheim
Fuji
Fish and Richardson
AstraZeneca
Daiichi Sankyo
Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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