Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075635
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ETOPOSIDE | ETOPOSIDE | 50MG | CAPSULE;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/19/2001 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75635.ap..pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/75-635_Etoposide.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/23/2018 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2006 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/28/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |