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
New Drug Application (NDA): 018053
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 |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription |
AP |
No | No |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.75% | 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 |
|---|---|---|---|---|---|---|---|
| 04/17/1978 | 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 |
|---|---|---|---|---|---|
| 03/09/2021 | SUPPL-61 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018053s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018053Orig1s061ltr.pdf |
||
| 11/02/2018 | SUPPL-60 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018053s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018053Orig1s60Ltr.pdf |
||
| 01/11/2016 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/2014 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/2015 | SUPPL-55 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018053s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018053Orig1s055ltr.pdf |
||
| 04/07/2010 | SUPPL-52 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2002 | SUPPL-44 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/02/1999 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 04/07/1999 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-40 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 11/04/1996 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/1996 | SUPPL-38 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/11/1991 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 01/29/1992 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/04/1990 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 04/07/1988 | SUPPL-31 | 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 |
|---|---|---|---|---|---|
| 03/09/2021 | SUPPL-61 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018053s061lbl.pdf | |
| 11/02/2018 | SUPPL-60 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018053s060lbl.pdf | |
| 07/10/2015 | SUPPL-55 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018053s055lbl.pdf |
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 |
INJECTABLE;INJECTION; 0.25%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 207183 | AUROBINDO PHARMA LTD |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 205141 | HIKMA PHARMS |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 018053 | HOSPIRA |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 070583 | HOSPIRA |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 070586 | HOSPIRA |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 070590 | HOSPIRA |
| BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 203895 | AUROBINDO PHARMA LTD |
| BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 204842 | HIKMA PHARMS |
| MARCAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | Yes | AP | 016964 | HOSPIRA |
| MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | Yes | AP | 016964 | HOSPIRA |
| SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 018304 | FRESENIUS KABI USA |
| SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 070552 | FRESENIUS KABI USA |
INJECTABLE;INJECTION; 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;INJECTION | Prescription | No | AP | 018053 | HOSPIRA |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;INJECTION | Prescription | No | AP | 070585 | HOSPIRA |
| BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;INJECTION | Prescription | No | AP | 203895 | AUROBINDO PHARMA LTD |
| BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;INJECTION | Prescription | No | AP | 204842 | HIKMA PHARMS |
| MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;INJECTION | Prescription | Yes | AP | 016964 | HOSPIRA |
| SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;INJECTION | Prescription | No | AP | 018304 | FRESENIUS KABI USA |
| SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;INJECTION | Prescription | No | AP | 070554 | FRESENIUS KABI USA |
حتما بخوانید : ADALAT CC از شرکت ALVOGEN
منبع : www.accessdata.fda.gov
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