Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204960
Company: HENGRUI PHARMA
Company: HENGRUI PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 10MG BASE/ML | 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 |
|---|---|---|---|---|---|---|---|
| 01/27/2017 | ORIG-1 | Approval |
Letter (PDF)
|
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 |
|---|---|---|---|---|---|
| 02/06/2023 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/06/2023 | SUPPL-15 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/31/2020 | SUPPL-8 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |