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 CHLORIDE 10% IN PLASTIC CONTAINER از شرکت HOSPIRA
New Drug Application (NDA): 021117
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER | CALCIUM CHLORIDE | 100MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 01/28/2000 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21117ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/25/2018 | SUPPL-15 | Labeling-Package Insert, Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021117s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021117Orig1s015Ltr.pdf |
||
| 03/18/2003 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21117scs002ltr.pdf |
|
| 09/01/2000 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/25/2018 | SUPPL-15 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021117s015lbl.pdf | |
| 07/25/2018 | SUPPL-15 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021117s015lbl.pdf |
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 100MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209088 | AM REGENT |
| CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203477 | INTL MEDICATION SYS |
| CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211553 | MEDEFIL INC |
| CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER | CALCIUM CHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 021117 | HOSPIRA |
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