Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 014901
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | AB | Yes | Yes |
| KENALOG-80 | TRIAMCINOLONE ACETONIDE | 80MG/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/09/2024 | SUPPL-55 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/014901Orig1s055lbl.pdf | |
| 06/05/2024 | SUPPL-54 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/014901s054lbl.pdf | |
| 06/05/2024 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/014901s054lbl.pdf | |
| 04/12/2019 | SUPPL-47 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/014901Orig1s047lbl.pdf | |
| 06/22/2018 | SUPPL-45 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014901s045lbl.pdf | |
| 03/29/2018 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014901s044lbl.pdf | |
| 07/03/2014 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014901s042lbledt.pdf | |
| 07/15/2011 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014901s039lbl.pdf | |
| 06/16/2011 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014901s038lbl.pdf | |
| 01/28/2010 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012041s036,014901s037lbl.pdf | |
| 11/20/2006 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014901s034lbl.pdf |