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Last Updated: September 19, 2020

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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 nine 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. Twenty-three suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 203312
Tradename:RYTARY
Applicant:Impax Labs Inc
Ingredient:carbidopa; levodopa
Patents:9
Pharmacology for NDA: 203312
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 Amneal Pharmaceuticals LLC 64896-661 64896-661-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-01)
RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312 NDA Amneal Pharmaceuticals LLC 64896-661 64896-661-09 25 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-09)
Paragraph IV (Patent) Challenges for 203312
Tradename Dosage Ingredient NDA Submissiondate
RYTARY CAPSULE, EXTENDED RELEASE;ORAL carbidopa; levodopa 203312 2015-06-24
RYTARY CAPSULE, EXTENDED RELEASE;ORAL carbidopa; levodopa 203312 2015-06-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength23.75MG;95MG
Approval Date:Jan 7, 2015TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 29, 2022Product Flag?YSubstance Flag?Delist Request?Y
Patented Use:TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Patent:  Start TrialPatent Expiration:Dec 26, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PARKINSON'S DISEASE
Patent:  Start TrialPatent Expiration:Dec 26, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION

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