Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017555
Company: ORGANON
Company: ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SINEMET | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| SINEMET | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | AB | Yes | No |
| SINEMET | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/19/2026 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/017555s076lbl.pdf | |
| 03/03/2020 | SUPPL-72 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017555s072lbl.pdf | |
| 07/17/2014 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf | |
| 07/17/2014 | SUPPL-68 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf | |
| 07/17/2014 | SUPPL-56 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf | |
| 02/01/2011 | SUPPL-70 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017555s070lbl.pdf |
| 12/31/2008 | SUPPL-69 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017555s069lbl.pdf |