Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019219
Company: ALLERGAN

Products on NDA 19219

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

Labels for NDA 019219

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2017	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019219s029lbl.pdf
08/08/2001	SUPPL-20	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19219s20lbl.pdf