Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217174
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | 1GM/50ML (20MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | 2GM/100ML (20MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/05/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217174Orig1s000ltr.pdf |
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 |