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
BIVALIRUDIN از شرکت FRESENIUS KABI USA
Abbreviated New Drug Application (ANDA): 090189
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;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 |
|---|---|---|---|---|---|---|---|
| 10/28/2016 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090189Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/14/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
BIVALIRUDIN
INJECTABLE;INTRAVENOUS; 250MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ANGIOMAX | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 020873 | SANDOZ INC |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206551 | ACCORD HLTHCARE |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 201577 | DR REDDYS LABS LTD |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 205962 | EUGIA PHARMA |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090189 | FRESENIUS KABI USA |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 213078 | HAINAN POLY PHARM |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 091602 | HONG KONG |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090811 | HOSPIRA INC |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090816 | HOSPIRA INC |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202471 | MYLAN INSTITUTIONAL |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 210031 | SHUANGCHENG |
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