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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021485
Company: ORION PHARMA

Other Important Information from FDA

Products on NDA 21485

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

Labels for NDA 021485

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2026	SUPPL-48	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021485s048lbl.pdf
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

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