Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021918
Company: LAB SALVAT

• Summary Review

Products on NDA 21918

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CETRAXAL	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS;OTIC	Prescription	AB	Yes	Yes

Labels for NDA 021918

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021918lbl.pdf