Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021201
Company: CHEMISCH FBRK KRSSLR
Company: CHEMISCH FBRK KRSSLR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ASCLERA | POLIDOCANOL | 10MG/2ML (5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | No |
| ASCLERA | POLIDOCANOL | 20MG/2ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/29/2019 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021201s004lbl.pdf | |
| 03/01/2018 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021201s002lbl.pdf | |
| 03/30/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021201lbl.pdf |