Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019856
Company: ORGANON LLC
Company: ORGANON LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SINEMET CR | CARBIDOPA; LEVODOPA | 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| SINEMET CR | CARBIDOPA; LEVODOPA | 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/30/1991 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/17/2014 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf | |
| 02/01/2011 | SUPPL-27 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019856s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017555s070,019856s027ltr.pdf | |
| 12/31/2008 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019856s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019856s025ltr.pdf | |
| 07/17/2014 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf | |
| 09/05/2002 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/2001 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/2001 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/2001 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf | |
| 05/02/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/06/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/1999 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/04/1999 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/10/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 05/10/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1996 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/07/1993 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/24/1992 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/10/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/17/2014 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf | |
| 07/17/2014 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf | |
| 07/17/2014 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf | |
| 02/01/2011 | SUPPL-27 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019856s027lbl.pdf |
| 12/31/2008 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019856s025lbl.pdf |