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
CARBOCAINE از شرکت HOSPIRA
New Drug Application (NDA): 012250
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBOCAINE | MEPIVACAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription |
AP |
Yes | Yes |
| CARBOCAINE | MEPIVACAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription |
AP |
Yes | Yes |
| CARBOCAINE | MEPIVACAINE HYDROCHLORIDE | 1.5% | INJECTABLE;INJECTION | Prescription |
AP |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 05/17/1960 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
PRIORITY |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/02/2018 | SUPPL-37 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012250s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012250Orig1s037Ltr.pdf |
||
| 02/19/2010 | SUPPL-33 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012250s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012250s033ltr.pdf |
||
| 09/28/2005 | SUPPL-28 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012250s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/012250s028ltr.pdf |
||
| 01/31/2001 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 05/21/1991 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1999 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 03/15/1985 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/30/1984 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/29/1987 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/21/1981 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/1980 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/15/1978 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/26/1979 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/06/1976 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/1975 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/15/1974 | SUPPL-7 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/02/2018 | SUPPL-37 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012250s037lbl.pdf | |
| 02/19/2010 | SUPPL-33 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012250s033lbl.pdf | |
| 09/28/2005 | SUPPL-28 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012250s028lbl.pdf |
CARBOCAINE
INJECTABLE;INJECTION; 1%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBOCAINE | MEPIVACAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | Yes | AP | 012250 | HOSPIRA |
| POLOCAINE | MEPIVACAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 089407 | FRESENIUS KABI USA |
| POLOCAINE-MPF | MEPIVACAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 089406 | FRESENIUS KABI USA |
INJECTABLE;INJECTION; 2%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBOCAINE | MEPIVACAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | Yes | AP | 012250 | HOSPIRA |
| POLOCAINE | MEPIVACAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 089410 | FRESENIUS KABI USA |
| POLOCAINE-MPF | MEPIVACAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 089409 | FRESENIUS KABI USA |
INJECTABLE;INJECTION; 1.5%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBOCAINE | MEPIVACAINE HYDROCHLORIDE | 1.5% | INJECTABLE;INJECTION | Prescription | Yes | AP | 012250 | HOSPIRA |
| POLOCAINE-MPF | MEPIVACAINE HYDROCHLORIDE | 1.5% | INJECTABLE;INJECTION | Prescription | No | AP | 089408 | FRESENIUS KABI USA |
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