APPLICATION
ANDA075861
TYPE
ANDA
ORIGINAL APPROVAL
2001-06-22
LATEST ACTION
2023-04-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LEVOCARNITINEPrescription
LEVOCARNITINE 200MG/ML · INJECTABLE · INJECTION
Approval history
2023-04-25Manufacturing (CMC) · Supplement 12 · unknownAP
2022-12-15Manufacturing (CMC) · Supplement 11AP
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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