APPLICATION
ANDA075242
TYPE
ANDA
ORIGINAL APPROVAL
1999-09-30
LATEST ACTION
2001-09-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LABETALOL HYDROCHLORIDEDiscontinued
LABETALOL HYDROCHLORIDE 5MG/ML · INJECTABLE · INJECTION
Approval history
2001-09-17Manufacturing (CMC) · Supplement 1AP
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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