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Generated: November 15, 2018

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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-five suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for 021918
Tradename:CETRAXAL
Applicant:Wraser Pharms
Ingredient:ciprofloxacin hydrochloride
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

Profile 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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