Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020457
Company: CHEPLAPHARM
Company: CHEPLAPHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ETOPOPHOS PRESERVATIVE FREE | ETOPOSIDE PHOSPHATE | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/02/2019 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020457s019lbl.pdf | |
| 05/23/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020457s016lbl.pdf | |
| 11/09/2016 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020457s015lbl.pdf | |
| 07/30/2015 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020457s014lbl.pdf | |
| 03/17/2011 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020457s013lbl.pdf |