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 KIT از شرکت HOSPIRA
New Drug Application (NDA): 019978
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE KIT | BUPIVACAINE HYDROCHLORIDE | 0.075% | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| BUPIVACAINE HYDROCHLORIDE KIT | BUPIVACAINE HYDROCHLORIDE | 0.114% | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| BUPIVACAINE HYDROCHLORIDE KIT | BUPIVACAINE HYDROCHLORIDE | 0.23% | INJECTABLE;INJECTION | Discontinued |
None |
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 |
|---|---|---|---|---|---|---|---|
| 09/03/1992 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/21/1999 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/23/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/1995 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/26/1994 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 02/26/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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