Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208418
Company: FRESENIUS KABI USA
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 | AP | Yes | Yes |
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | 1GM/50ML (20MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | 2GM/100ML (20MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | 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 |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208418s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208418Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208418Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/17/2022 | SUPPL-13 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208418Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208418Orig1s013ltr.pdf | |
| 12/29/2021 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208418s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208418Orig1s011ltr.pdf | |
| 06/17/2021 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
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 |
Review (PDF)
|
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 |
|---|---|---|---|---|---|
| 10/17/2022 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208418Orig1s013lbl.pdf | |
| 10/17/2022 | SUPPL-13 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208418Orig1s013lbl.pdf | |
| 12/29/2021 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208418s011lbl.pdf | |
| 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 |
CALCIUM GLUCONATE
SOLUTION;INTRAVENOUS; 1GM/10ML (100MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216611 | AMNEAL |
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 208418 | FRESENIUS KABI USA |
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213071 | NIVAGEN PHARMS INC |
SOLUTION;INTRAVENOUS; 5GM/50ML (100MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216611 | AMNEAL |
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 208418 | FRESENIUS KABI USA |
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213071 | NIVAGEN PHARMS INC |
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217689 | SOMERSET |
SOLUTION;INTRAVENOUS; 10GM/100ML (100MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216611 | AMNEAL |
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216541 | B BRAUN MEDICAL INC |
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 208418 | FRESENIUS KABI USA |
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213071 | NIVAGEN PHARMS INC |
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217689 | SOMERSET |
CALCIUM GLUCONATE IN SODIUM CHLORIDE
SOLUTION;INTRAVENOUS; 1GM/50ML (20MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | 1GM/50ML (20MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217174 | AMNEAL |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | 1GM/50ML (20MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 208418 | FRESENIUS KABI USA |
SOLUTION;INTRAVENOUS; 2GM/100ML (20MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | 2GM/100ML (20MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217174 | AMNEAL |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | 2GM/100ML (20MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 208418 | FRESENIUS KABI USA |