Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019270
Company: SANDOZ INC

Products on NDA 19270

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETOPTIC	BETAXOLOL HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	Yes	Yes

Labels for NDA 019270

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/14/2006	SUPPL-31	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19270s031lbl.pdf