Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207563
Company: INGENUS PHARMS LLC
Company: INGENUS PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/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 |
|---|---|---|---|---|---|---|---|
| 08/31/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207563Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/28/2025 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/23/2020 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 09/06/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/06/2019 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |