SEBELA IRELAND LTD Application 019425

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRANDATE	LABETALOL HYDROCHLORIDE	INJECTABLE;INJECTION	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Document, Submission type, Date table
Document	Submission type	Date
17390	SUPPL	2010-11-30
33741	SUPPL	2010-11-22