Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020805
Company: SANDOZ

Products on NDA 20805

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIPRO HC	CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE	EQ 0.2% BASE;1%	SUSPENSION/DROPS;OTIC	Prescription	AB	Yes	Yes

Labels for NDA 020805

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/20/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020805s011lbl.pdf
02/10/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20805-mr.pdf