APPLICATION
ANDA075239
TYPE
ANDA
ORIGINAL APPROVAL
1999-11-29
LATEST ACTION
2012-09-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LABETALOL HYDROCHLORIDEPrescription
LABETALOL HYDROCHLORIDE 5MG/ML · INJECTABLE · INJECTION
Approval history
2001-02-28Labeling · Supplement 3AP
2001-02-28Manufacturing (CMC) · Supplement 2AP
2001-02-14Manufacturing (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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