Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009768
Company: CONCORDIA
Company: CONCORDIA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/12/2023 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/009768s054lbl.pdf | |
| 07/24/2023 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/009768s060lbl.pdf | |
| 05/03/2022 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/009768s056lbl.pdf | |
| 05/03/2021 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/009768s053lbl.pdf | |
| 01/05/2019 | SUPPL-51 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/009768Orig1s051lbl.pdf | |
| 01/05/2019 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/009768Orig1s051lbl.pdf | |
| 01/27/2017 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf | |
| 01/27/2017 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf | |
| 01/27/2017 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf | |
| 06/20/2007 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009768s041lbl.pdf |