Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022202
Company: COSETTE
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZIPSOR | DICLOFENAC POTASSIUM | 25MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/21/2024 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022202s016lbl.pdf | |
| 05/25/2021 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022202s013s014lbl.pdf | |
| 05/25/2021 | SUPPL-13 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022202s013s014lbl.pdf | |
| 05/09/2016 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022202s011lbl.pdf | |
| 05/09/2016 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022202s011lbl.pdf | |
| 05/09/2016 | SUPPL-11 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022202s011lbl.pdf | |
| 06/16/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022202lbl.pdf |