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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 six suppliers. There are two patents protecting this drug and one Paragraph IV challenge. 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. Six suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Summary for NDA: 021485

Tradename:
STALEVO 100
Applicant:
Orion Pharma
Ingredient:
carbidopa; entacapone; levodopa
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 021485

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 Novartis Pharmaceuticals Corporation 0078-0407 0078-0407-05 100 TABLET, FILM COATED in 1 BOTTLE (0078-0407-05)
STALEVO 100
carbidopa; entacapone; levodopa
TABLET;ORAL 021485 NDA Novartis Pharmaceuticals Corporation 0078-0408 0078-0408-05 100 TABLET, FILM COATED in 1 BOTTLE (0078-0408-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;200MG;50MG
Approval Date:Jun 11, 2003TE:ABRLD:Yes
Patent:6,797,732Patent Expiration:Jun 29, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:6,500,867Patent Expiration:Jun 29, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PARKINSON'S DISEASE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;200MG;100MG
Approval Date:Jun 11, 2003TE:ABRLD:No
Patent:6,797,732Patent Expiration:Jun 29, 2020Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021485

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma
STALEVO 50
carbidopa; entacapone; levodopa
TABLET;ORAL021485-001Jun 11, 20034,963,590► subscribe
Orion Pharma
STALEVO 75
carbidopa; entacapone; levodopa
TABLET;ORAL021485-005Aug 29, 20085,446,194► subscribe
Orion Pharma
STALEVO 125
carbidopa; entacapone; levodopa
TABLET;ORAL021485-006Aug 29, 20085,446,194► subscribe
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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. thinkBiotech performs no independent verifification 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.

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