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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/02/1975 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf | |
| 02/01/2011 | SUPPL-70 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017555s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017555s070,019856s027ltr.pdf | |
| 12/31/2008 | SUPPL-69 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017555s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017555s069ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/017555Orig1s069.pdf | |
| 07/17/2014 | SUPPL-68 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf | |
| 09/05/2002 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/2001 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/2001 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/2001 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/2001 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/2001 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-56 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf | |
| 04/11/2001 | SUPPL-55 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf |
| 06/06/2000 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/04/2000 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/2001 | SUPPL-51 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf |
| 04/11/2001 | SUPPL-50 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf |
| 11/26/1997 | SUPPL-48 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/04/1997 | SUPPL-47 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/07/1997 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/11/2001 | SUPPL-45 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf |
| 05/16/1996 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/13/1995 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/11/2001 | SUPPL-40 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf |
| 04/11/2001 | SUPPL-39 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf |
| 04/11/2001 | SUPPL-38 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf |
| 04/11/2001 | SUPPL-37 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf |
| 04/11/2001 | SUPPL-36 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf |
| 04/21/1988 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 02/26/1988 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 07/12/1985 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/30/1985 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 05/06/1985 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1984 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1984 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1984 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 05/04/1983 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/1981 | SUPPL-20 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/09/1983 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/02/1981 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 09/09/1980 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 01/12/1981 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/11/1980 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/29/1980 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/29/1980 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1980 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/22/1979 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/13/1978 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/1980 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/24/1978 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/29/1977 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/25/1978 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/26/1978 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 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 |
SINEMET
TABLET;ORAL; 10MG;100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 074260 | ACTAVIS ELIZABETH |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 077120 | APOTEX INC |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 216537 | AUROBINDO PHARMA LTD |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 073618 | DR REDDYS LABS SA |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 090324 | MYLAN |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 216505 | RUBICON |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 214092 | SCIEGEN PHARMS INC |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 078536 | SUN PHARM INDS |
| SINEMET | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | Yes | AB | 017555 | ORGANON |
TABLET;ORAL; 25MG;250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 074260 | ACTAVIS ELIZABETH |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 077120 | APOTEX INC |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 216537 | AUROBINDO PHARMA LTD |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 073607 | DR REDDYS LABS SA |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 090324 | MYLAN |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 216505 | RUBICON |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 214092 | SCIEGEN PHARMS INC |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 078536 | SUN PHARM INDS |
| SINEMET | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | Yes | AB | 017555 | ORGANON |
TABLET;ORAL; 25MG;100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 074260 | ACTAVIS ELIZABETH |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 077120 | APOTEX INC |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 216537 | AUROBINDO PHARMA LTD |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 073589 | DR REDDYS LABS SA |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 090324 | MYLAN |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 216505 | RUBICON |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 214092 | SCIEGEN PHARMS INC |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 078536 | SUN PHARM INDS |
| SINEMET | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | Yes | AB | 017555 | ORGANON |