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FDA NDA · NDA022562

CARBAGLU

carglumic acid

Sponsor: RECORDATI RARE

APPLICATION
NDA022562
TYPE
NDA
ORIGINAL APPROVAL
2010-03-18
LATEST ACTION
2024-01-19
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription

Products

CARBAGLU · ReferencePrescription
CARGLUMIC ACID 200MG · TABLET, FOR SUSPENSION · ORAL

Approval history

2024-01-19Labeling · Supplement 14 · standard — Label ↗AP
2021-08-05Labeling · Supplement 13 · standard — Label ↗AP
2021-01-22Efficacy · Supplement 8 · priority — Letter ↗AP
2021-01-22Efficacy · Supplement 9 · priority — Letter ↗AP
2020-08-26Labeling · Supplement 12 · standard — Letter ↗AP
2019-12-23Labeling · Supplement 11 · standard — Letter ↗AP
2017-11-16Labeling · Supplement 5 · standard — Label ↗AP
2015-11-05Manufacturing (CMC) · Supplement 4 · priorityAP
2014-01-23Manufacturing (CMC) · Supplement 3 · priorityAP
2013-08-05Labeling · Supplement 2 · standard — Label ↗AP
2013-07-22Manufacturing (CMC) · Supplement 1 · priorityAP
2010-03-18Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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