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
CARDIOPLEGIC IN PLASTIC CONTAINER از شرکت BAXTER HLTHCARE
Abbreviated New Drug Application (ANDA): 075323
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARDIOPLEGIC IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML | SOLUTION;PERFUSION, CARDIAC | Prescription |
AT |
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 |
|---|---|---|---|---|---|---|---|
| 04/21/2000 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75323ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/04/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
CARDIOPLEGIC IN PLASTIC CONTAINER
SOLUTION;PERFUSION, CARDIAC; 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARDIOPLEGIC IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML | SOLUTION;PERFUSION, CARDIAC | Prescription | No | AT | 075323 | BAXTER HLTHCARE |
| PLEGISOL IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML | SOLUTION;PERFUSION, CARDIAC | Prescription | Yes | AT | 018608 | HOSPIRA |
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