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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022562
Company: RECORDATI RARE
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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
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