Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090675
Company: HENGRUI PHARMA
Company: HENGRUI PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/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 |
|---|---|---|---|---|---|---|---|
| 12/16/2011 | 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 |
|---|---|---|---|---|---|
| 12/16/2011 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 12/16/2011 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
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| 12/16/2011 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 12/16/2011 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 05/23/2025 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/23/2025 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/23/2025 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/23/2025 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/29/2013 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |