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Details for New Drug Application (NDA): 203312

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NDA 203312 describes RYTARY, which is a drug marketed by Impax Labs Inc and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and two Paragraph IV challenges. Additional details are available on the RYTARY profile page.

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

Summary for NDA: 203312

Tradename:
RYTARY
Applicant:
Impax Labs Inc
Ingredient:
carbidopa; levodopa
Patents:7
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203312

Mechanism of ActionDOPA Decarboxylase Inhibitors

Suppliers and Packaging for NDA: 203312

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL 203312 NDA Impax Specialty Pharma 64896-661 64896-661-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-01)
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL 203312 NDA Impax Specialty Pharma 64896-661 64896-661-09 25 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-09)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength23.75MG;95MG
Approval Date:Jan 7, 2015TE:RLD:No
Patent:9,089,608Patent Expiration:Dec 26, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:9,089,607Patent Expiration:Dec 26, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA
Regulatory Exclusivity Expiration:Jan 7, 2018
Regulatory Exclusivity Use:NEW DOSAGE FORM


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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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