Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214575
Company: EUGIA PHARMA
Company: EUGIA PHARMA
| 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 |
|---|---|---|---|---|---|---|---|
| 06/25/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/30/2024 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |