Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021516
Company: BAUSCH AND LOMB

Products on NDA 21516

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISTALOL	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT2	Yes	Yes

Labels for NDA 021516

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/17/2013	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021516s005lbl.pdf
06/04/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21516_istalol_lbl.pdf