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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022562
Company: RECORDATI RARE

Products on NDA 022562

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARBAGLU	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022562

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/18/2010	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022562lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022562s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022562s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/19/2024	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022562s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022562Orig1s014ltr.pdf
08/05/2021	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022562s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022562Orig1s013ltr.pdf
08/26/2020	SUPPL-12	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022562Orig1s012ltr.pdf
12/23/2019	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022562s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022562Orig1s011ltr.pdf
01/22/2021	SUPPL-9	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022562s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022562Orig1s008, s009ltr.pdf
01/22/2021	SUPPL-8	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022562s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022562Orig1s008, s009ltr.pdf
11/16/2017	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022562s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022562Orig1s005ltr.pdf
11/05/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/23/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/05/2013	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022562s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022562Orig1s002ltr.pdf
07/22/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022562

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/19/2024	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022562s014lbl.pdf
08/05/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022562s013lbl.pdf
01/22/2021	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022562s008s009lbl.pdf
01/22/2021	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022562s008s009lbl.pdf
12/23/2019	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022562s011lbl.pdf
11/16/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022562s005lbl.pdf
08/05/2013	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022562s002lbl.pdf
03/18/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022562lbl.pdf

Therapeutic Equivalents for NDA 022562

CARBAGLU

TABLET, FOR SUSPENSION;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARBAGLU	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION;ORAL	Prescription	Yes	AB	022562	RECORDATI RARE
CARGLUMIC ACID	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	213395	NAVINTA LLC
CARGLUMIC ACID	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	213729	NOVITIUM PHARMA

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