Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021485
Company: ORION PHARMA
Company: ORION PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STALEVO 100 | CARBIDOPA; ENTACAPONE; LEVODOPA | 25MG;200MG;100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| STALEVO 125 | CARBIDOPA; ENTACAPONE; LEVODOPA | 31.25MG;200MG;125MG | TABLET;ORAL | Prescription | AB | Yes | No |
| STALEVO 150 | CARBIDOPA; ENTACAPONE; LEVODOPA | 37.5MG;200MG;150MG | TABLET;ORAL | Prescription | AB | Yes | No |
| STALEVO 200 | CARBIDOPA; ENTACAPONE; LEVODOPA | 50MG;200MG;200MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| STALEVO 50 | CARBIDOPA; ENTACAPONE; LEVODOPA | 12.5MG;200MG;50MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| STALEVO 75 | CARBIDOPA; ENTACAPONE; LEVODOPA | 18.75MG;200MG;75MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/11/2003 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21485_stalevo_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21485ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-485_Stalevo.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/30/2019 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021485s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021485Orig1s042ltr.pdf | |
| 09/21/2018 | SUPPL-38 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021485Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021485Orig1s038ltr.pdf | ||
| 02/25/2016 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/2016 | SUPPL-35 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021485s033lbl.pdf | |
| 01/29/2016 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/2016 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021485s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020796Orig1s026,021485Orig1s033ltr.pdf | |
| 02/14/2014 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/2014 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/2014 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021485s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021485Orig1s028,s029ltr.pdf | |
| 07/18/2014 | SUPPL-28 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021485s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021485Orig1s028,s029ltr.pdf | |
| 04/05/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/2010 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021485s20lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020796s015,021485s020ltr.pdf | |
| 09/26/2008 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021485s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021485s017ltr.pdf | |
| 08/29/2008 | SUPPL-16 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021485s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021485s016ltr.pdf | |
| 02/02/2009 | SUPPL-12 | Labeling |
Label (PDF)
Label (PDF) Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012ltr(corrected).pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012(2)ltr.pdf | |
| 08/02/2007 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021485s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/0214855s011ltr.pdf | |
| 02/02/2009 | SUPPL-8 | Labeling |
Label (PDF)
Label (PDF) Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012ltr(corrected).pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012(2)ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/30/2019 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021485s042lbl.pdf | |
| 09/21/2018 | SUPPL-38 | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021485Orig1s038lbl.pdf | ||
| 02/22/2016 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021485s033lbl.pdf | |
| 02/18/2016 | SUPPL-35 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021485s033lbl.pdf |
| 07/18/2014 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021485s028s029lbl.pdf | |
| 07/18/2014 | SUPPL-28 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021485s028s029lbl.pdf | |
| 10/11/2010 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021485s20lbl.pdf | |
| 02/02/2009 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf | |
| 02/02/2009 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf | |
| 02/02/2009 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf | |
| 02/02/2009 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf | |
| 09/26/2008 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021485s017lbl.pdf | |
| 08/29/2008 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021485s016lbl.pdf | |
| 08/29/2008 | SUPPL-16 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021485s016lbl.pdf | |
| 08/02/2007 | SUPPL-11 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021485s011lbl.pdf | |
| 06/11/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21485_stalevo_lbl.pdf |
STALEVO 100
TABLET;ORAL; 25MG;200MG;100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 25MG;200MG;100MG | TABLET;ORAL | Prescription | No | AB | 213212 | RISING |
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 25MG;200MG;100MG | TABLET;ORAL | Prescription | No | AB | 079085 | SUN PHARM |
| STALEVO 100 | CARBIDOPA; ENTACAPONE; LEVODOPA | 25MG;200MG;100MG | TABLET;ORAL | Prescription | Yes | AB | 021485 | ORION PHARMA |
STALEVO 125
TABLET;ORAL; 31.25MG;200MG;125MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 31.25MG;200MG;125MG | TABLET;ORAL | Prescription | No | AB | 213212 | RISING |
| STALEVO 125 | CARBIDOPA; ENTACAPONE; LEVODOPA | 31.25MG;200MG;125MG | TABLET;ORAL | Prescription | Yes | AB | 021485 | ORION PHARMA |
STALEVO 150
TABLET;ORAL; 37.5MG;200MG;150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 37.5MG;200MG;150MG | TABLET;ORAL | Prescription | No | AB | 213212 | RISING |
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 37.5MG;200MG;150MG | TABLET;ORAL | Prescription | No | AB | 079085 | SUN PHARM |
| STALEVO 150 | CARBIDOPA; ENTACAPONE; LEVODOPA | 37.5MG;200MG;150MG | TABLET;ORAL | Prescription | Yes | AB | 021485 | ORION PHARMA |
STALEVO 200
TABLET;ORAL; 50MG;200MG;200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 50MG;200MG;200MG | TABLET;ORAL | Prescription | No | AB | 213212 | RISING |
| STALEVO 200 | CARBIDOPA; ENTACAPONE; LEVODOPA | 50MG;200MG;200MG | TABLET;ORAL | Prescription | Yes | AB | 021485 | ORION PHARMA |
STALEVO 50
TABLET;ORAL; 12.5MG;200MG;50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 12.5MG;200MG;50MG | TABLET;ORAL | Prescription | No | AB | 213212 | RISING |
| STALEVO 50 | CARBIDOPA; ENTACAPONE; LEVODOPA | 12.5MG;200MG;50MG | TABLET;ORAL | Prescription | Yes | AB | 021485 | ORION PHARMA |
STALEVO 75
TABLET;ORAL; 18.75MG;200MG;75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 18.75MG;200MG;75MG | TABLET;ORAL | Prescription | No | AB | 213212 | RISING |
| STALEVO 75 | CARBIDOPA; ENTACAPONE; LEVODOPA | 18.75MG;200MG;75MG | TABLET;ORAL | Prescription | Yes | AB | 021485 | ORION PHARMA |