Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021292
Company: EMD SERONO INC
Company: EMD SERONO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EUTHYROX | LEVOTHYROXINE SODIUM | 0.025MG | TABLET;ORAL | Discontinued | None | No | No |
| EUTHYROX | LEVOTHYROXINE SODIUM | 0.05MG | TABLET;ORAL | Discontinued | None | No | No |
| EUTHYROX | LEVOTHYROXINE SODIUM | 0.075MG | TABLET;ORAL | Discontinued | None | No | No |
| EUTHYROX | LEVOTHYROXINE SODIUM | 0.088MG | TABLET;ORAL | Discontinued | None | No | No |
| EUTHYROX | LEVOTHYROXINE SODIUM | 0.1MG | TABLET;ORAL | Discontinued | None | No | No |
| EUTHYROX | LEVOTHYROXINE SODIUM | 0.112MG | TABLET;ORAL | Discontinued | None | No | No |
| EUTHYROX | LEVOTHYROXINE SODIUM | 0.125MG | TABLET;ORAL | Discontinued | None | No | No |
| EUTHYROX | LEVOTHYROXINE SODIUM | 0.137MG | TABLET;ORAL | Discontinued | None | No | No |
| EUTHYROX | LEVOTHYROXINE SODIUM | 0.15MG | TABLET;ORAL | Discontinued | None | No | No |
| EUTHYROX | LEVOTHYROXINE SODIUM | 0.175MG | TABLET;ORAL | Discontinued | None | No | No |
| EUTHYROX | LEVOTHYROXINE SODIUM | 0.2MG | TABLET;ORAL | Discontinued | None | No | No |
| EUTHYROX | LEVOTHYROXINE SODIUM | 0.3MG | TABLET;ORAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/27/2022 | SUPPL-10 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021292Orig1s010lbl.pdf | |
| 04/27/2022 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021292Orig1s010lbl.pdf | |
| 09/14/2018 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf | |
| 09/14/2018 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf | |
| 09/14/2018 | SUPPL-4 | Efficacy-Accelerated Approval Confirmatory Study | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf | |
| 03/26/2009 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021292s002lbl.pdf | |
| 05/31/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21292lbl.pdf |