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
CISATRACURIUM BESYLATE PRESERVATIVE FREE از شرکت JIANGSU HENGRUI MED
Abbreviated New Drug Application (ANDA): 204960
Company: JIANGSU HENGRUI MED
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription |
AP |
No | No |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 10MG BASE/ML | 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 |
|---|---|---|---|---|---|---|---|
| 01/27/2017 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204960Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/31/2020 | SUPPL-8 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
CISATRACURIUM BESYLATE PRESERVATIVE FREE
INJECTABLE;INJECTION; EQ 2MG BASE/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209144 | AUROBINDO PHARMA LTD |
| CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203183 | FRESENIUS KABI USA |
| CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203236 | HOSPIRA INC |
| CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203238 | HOSPIRA INC |
| CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209334 | JIANGSU HENGRUI MED |
| CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211668 | MEITHEAL |
| CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211669 | MEITHEAL |
| CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201836 | SAGENT PHARMS INC |
| CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 200159 | SANDOZ INC |
| CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209132 | SOMERSET |
| CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212171 | ZYDUS PHARMS |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209665 | AUROBINDO PHARMA LTD |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203182 | FRESENIUS KABI USA |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204960 | JIANGSU HENGRUI MED |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 200154 | SANDOZ INC |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206791 | SOMERSET THERAPS LLC |
| NIMBEX | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020551 | ABBVIE |
| NIMBEX PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020551 | ABBVIE |
INJECTABLE;INJECTION; EQ 10MG BASE/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203236 | HOSPIRA INC |
| CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211668 | MEITHEAL |
| CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201836 | SAGENT PHARMS INC |
| CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212171 | ZYDUS PHARMS |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203182 | FRESENIUS KABI USA |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204960 | JIANGSU HENGRUI MED |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 200154 | SANDOZ INC |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206791 | SOMERSET THERAPS LLC |
| NIMBEX PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020551 | ABBVIE |
منبع : www.accessdata.fda.gov
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