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 GLAND
Abbreviated New Drug Application (ANDA): 207092
Company: GLAND
| 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 |
|---|---|---|---|---|---|---|---|
| 09/29/2017 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207092Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/05/2019 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/05/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
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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