اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CARBAGLU از شرکت RECORDATI RARE
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 |
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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022562lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/05/2021 | SUPPL-13 | Labeling-Package Insert |
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 |
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 |
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 |
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 |
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 |
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 |
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. |
| 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 |
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 | 213729 | NOVITIUM PHARMA |
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