Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021485
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 None 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 None Yes Yes
STALEVO 50 CARBIDOPA; ENTACAPONE; LEVODOPA 12.5MG;200MG;50MG TABLET;ORAL Prescription None Yes Yes
STALEVO 75 CARBIDOPA; ENTACAPONE; LEVODOPA 18.75MG;200MG;75MG TABLET;ORAL Prescription 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
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-Container/Carton Labels, Labeling-Package Insert 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,s012(2)ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012ltr(corrected).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,s012(2)ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012ltr(corrected).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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021485s016lbl.pdf
08/29/2008 SUPPL-16 Labeling-Package Insert 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 079085 SUN PHARM
STALEVO 100 CARBIDOPA; ENTACAPONE; LEVODOPA 25MG;200MG;100MG TABLET;ORAL Prescription Yes AB 021485 ORION PHARMA

STALEVO 125

There are no Therapeutic Equivalents.

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 079085 SUN PHARM
STALEVO 150 CARBIDOPA; ENTACAPONE; LEVODOPA 37.5MG;200MG;150MG TABLET;ORAL Prescription Yes AB 021485 ORION PHARMA

STALEVO 200

There are no Therapeutic Equivalents.

STALEVO 50

There are no Therapeutic Equivalents.

STALEVO 75

There are no Therapeutic Equivalents.

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