Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010841
Company: RECORDATI RARE
Company: RECORDATI RARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PEGANONE | ETHOTOIN | 250MG | TABLET;ORAL | Discontinued | None | Yes | No |
| PEGANONE | ETHOTOIN | 500MG | TABLET;ORAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/07/2010 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010841s022lbl.pdf | |
| 06/07/2010 | SUPPL-22 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010841s022lbl.pdf | |
| 04/23/2009 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010841s021lbl.pdf | |
| 02/02/2007 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010841s020lbl.pdf |