Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203170
Company: HENGRUI PHARMA
Company: HENGRUI PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOCETAXEL | DOCETAXEL | 40MG/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 |
|---|---|---|---|---|---|---|---|
| 02/15/2017 | 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 |
|---|---|---|---|---|---|
| 09/04/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/04/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/28/2019 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 10/28/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |