Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 014602
Company: ORGANON
Company: ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CELESTONE SOLUSPAN | BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE | 3MG/ML;EQ 3MG BASE/ML | INJECTABLE;INJECTION | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/08/2024 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/014602s064lbl.pdf | |
| 06/05/2024 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/014602s068lbl.pdf | |
| 09/06/2022 | SUPPL-65 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/014602Orig1s065lbl.pdf | |
| 09/06/2022 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/014602Orig1s065lbl.pdf | |
| 04/10/2018 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014602s062lbl.pdf | |
| 02/09/2018 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014602s061lbl.pdf | |
| 02/04/2015 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/014602s059lbl.pdf | |
| 07/03/2014 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014602Orig1s058lbledt.pdf | |
| 06/24/2008 | SUPPL-47 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/014602s047lbl.pdf |