Details for New Drug Application (NDA): 021485

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NDA 021485 describes STALEVO 75, which is a drug marketed by Orion Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the STALEVO 75 profile page.

The generic ingredient in STALEVO 75 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Summary for 021485

Tradename:	STALEVO 75
Applicant:	Orion Pharma
Ingredient:	carbidopa; entacapone; levodopa
Patents:	0

Pharmacology for NDA: 021485

Mechanism of Action	Catechol O-Methyltransferase Inhibitors

Suppliers and Packaging for NDA: 021485

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-5613	0781-5613-01	100 TABLET, FILM COATED in 1 BOTTLE (0781-5613-01)
STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-5625	0781-5625-01	100 TABLET, FILM COATED in 1 BOTTLE (0781-5625-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG;200MG;50MG
Approval Date:	Jun 11, 2003	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG;200MG;100MG
Approval Date:	Jun 11, 2003	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	37.5MG;200MG;150MG
Approval Date:	Jun 11, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021485

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 50	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-001	Jun 11, 2003	⤷ Subscribe	⤷ Subscribe
Orion Pharma	STALEVO 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	⤷ Subscribe	⤷ Subscribe
Orion Pharma	STALEVO 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003	⤷ Subscribe	⤷ Subscribe
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