APPLICATION
ANDA079134
TYPE
ANDA
ORIGINAL APPROVAL
2010-02-03
LATEST ACTION
2015-06-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LABETALOL HYDROCHLORIDEDiscontinued
LABETALOL HYDROCHLORIDE 5MG/ML · INJECTABLE · INJECTION
Approval history
2015-06-22Labeling · Supplement 8 · standardAP
2015-03-17Labeling · Supplement 6 · standardAP
2012-08-24Labeling · Supplement 4AP
2010-02-03OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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