Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020666
Company: IMPAX LABS INC
Company: IMPAX LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALBENZA | ALBENDAZOLE | 200MG | TABLET;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/11/2019 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020666s012lbl.pdf | |
| 10/31/2018 | SUPPL-11 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020666s011lbl.pdf | |
| 10/31/2018 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020666s011lbl.pdf | |
| 12/20/2017 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020666s010lbl.pdf | |
| 06/11/2015 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020666s009lbl.pdf | |
| 10/20/2009 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf | |
| 10/20/2009 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf | |
| 08/20/2007 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020666s004lbl.pdf |