BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Argus Health
US Department of Justice
US Army
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

Formulation / Manufacturing:see details

Pharmacology for NDA: 021918


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
Fish and Richardson
Daiichi Sankyo
Farmers Insurance

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