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 AND EPINEPHRINE از شرکت HOSPIRA
Abbreviated New Drug Application (ANDA): 071168
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE | 0.5%;0.005MG/ML | INJECTABLE;INJECTION | Prescription |
AP |
No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/16/1988 | 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-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/16/2020 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/16/2020 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/16/2020 | SUPPL-29 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/19/2010 | SUPPL-20 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/071168s020lbl.pdf |
||
| 12/20/2002 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/22/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/29/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/04/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/21/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/19/2010 | SUPPL-20 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/071168s020lbl.pdf |
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
INJECTABLE;INJECTION; 0.5%;0.005MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE | 0.5%;0.005MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 071168 | HOSPIRA |
| BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE | 0.5%;0.005MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 071170 | HOSPIRA |
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