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): 071810
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;SPINAL | 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 |
|---|---|---|---|---|---|---|---|
| 12/11/1987 | 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 |
|---|---|---|---|---|---|
| 06/09/2020 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/25/2015 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/07/2010 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/15/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/08/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
BUPIVACAINE HYDROCHLORIDE
INJECTABLE;SPINAL; 0.75%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;SPINAL | Prescription | No | AP | 209087 | B BRAUN MEDICAL INC |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;SPINAL | Prescription | No | AP | 207266 | BAXTER HLTHCARE CORP |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;SPINAL | Prescription | No | AP | 071810 | HOSPIRA |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;SPINAL | Prescription | No | AP | 212822 | HUONS |
| MARCAINE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;SPINAL | Prescription | Yes | AP | 018692 | HOSPIRA |
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