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
CASPOFUNGIN ACETATE از شرکت FRESENIUS KABI USA
New Drug Application (NDA): 206110
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription |
AP |
No | No |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;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 |
|---|---|---|---|---|---|---|---|
| 12/30/2016 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206110lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/01/2021 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206110s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206110Orig1s003ltr.pdf |
||
| 06/28/2018 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206110s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206110Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/01/2021 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206110s003lbl.pdf | |
| 06/28/2018 | SUPPL-1 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206110s001lbl.pdf | |
| 06/28/2018 | SUPPL-1 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206110s001lbl.pdf | |
| 12/30/2016 | ORIG-1 | Approval | Label (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206110lbl.pdf |
CASPOFUNGIN ACETATE
POWDER;INTRAVENOUS; 50MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CANCIDAS | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 021227 | MERCK |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 206110 | FRESENIUS KABI USA |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 207092 | GLAND |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 200833 | JIANGSU HENGRUI MED |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 207650 | MYLAN LABS LTD |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 211263 | UBI |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 205923 | XELLIA PHARMS APS |
POWDER;INTRAVENOUS; 70MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CANCIDAS | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 021227 | MERCK |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 206110 | FRESENIUS KABI USA |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 207092 | GLAND |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 200833 | JIANGSU HENGRUI MED |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 211263 | UBI |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 205923 | XELLIA PHARMS APS |
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