Details for New Drug Application (NDA): 021485

✉ Email this page to a colleague

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. Four 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

Subscribe to access the full database, or Get Started Free
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	⤷ Get Started Free	⤷ Get Started Free
Orion Pharma	STALEVO 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	⤷ Get Started Free	⤷ Get Started Free
Orion Pharma	STALEVO 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003	⤷ Get Started Free	⤷ Get Started Free
Orion Pharma	STALEVO 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008	⤷ Get Started Free	⤷ Get Started Free
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.