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
BUPIVACAINE HYDROCHLORIDE از شرکت HOSPIRA
Abbreviated New Drug Application (ANDA): 070597
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/03/1987 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/06/2021 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/16/2020 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/16/2020 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2015 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/07/2010 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/21/2004 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 10/25/2002 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 11/02/1999 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/16/1999 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 05/05/1998 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/03/1996 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/04/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/26/1990 | SUPPL-1 | Labeling |
Label is not available on this site. |
BUPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION; 0.5%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 207183 | AUROBINDO PHARMA LTD |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 205141 | HIKMA PHARMS |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 018053 | HOSPIRA |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 070584 | HOSPIRA |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 070597 | HOSPIRA |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 070609 | HOSPIRA |
| BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 203895 | AUROBINDO PHARMA LTD |
| BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 204842 | HIKMA PHARMS |
| MARCAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | Yes | AP | 016964 | HOSPIRA |
| MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | Yes | AP | 016964 | HOSPIRA |
| SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 018304 | FRESENIUS KABI USA |
| SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 070553 | FRESENIUS KABI USA |
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