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
CALCIUM GLUCONATE از شرکت FRESENIUS KABI USA
New Drug Application (NDA): 208418
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION;INTRAVENOUS | Prescription |
None |
Yes | Yes |
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION;INTRAVENOUS | Prescription |
None |
Yes | Yes |
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION;INTRAVENOUS | Prescription |
None |
Yes | Yes |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | 1GM/50ML (20MG/ML) | SOLUTION;INTRAVENOUS | Prescription |
None |
Yes | Yes |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | 2GM/100ML (20MG/ML) | SOLUTION;INTRAVENOUS | Prescription |
None |
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 |
|---|---|---|---|---|---|---|---|
| 06/15/2017 | ORIG-1 | Approval |
Type 7 – Drug Already Marketed without Approved NDA |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208418s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/17/2021 | SUPPL-7 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/0208418s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208418Orig1s007ltr.pdf |
||
| 12/22/2017 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/208418Orig1s001.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/17/2021 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/0208418s007lbl.pdf | |
| 06/15/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208418s000lbl.pdf |
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