Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022562
Company: RECORDATI RARE
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 |
---|---|---|---|---|---|
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 |