Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019425
Company: SEBELA IRELAND LTD

Products on NDA 19425

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRANDATE	LABETALOL HYDROCHLORIDE	5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Labels for NDA 019425

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2010	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019425s021lbl.pdf