APPLICATION
ANDA213729
TYPE
ANDA
ORIGINAL APPROVAL
2021-10-13
LATEST ACTION
2024-05-30
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription
Products
CARGLUMIC ACIDPrescription
CARGLUMIC ACID 200MG · TABLET, FOR SUSPENSION · ORAL
Approval history
2024-05-30Labeling · Supplement 8 · standardAP
2022-06-22Manufacturing (CMC) · Supplement 1 · unknownAP
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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