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. Thirty-one 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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	23.75MG;95MG
Approval Date:	Jan 7, 2015	TE:		RLD:	Yes
Patent:	See Plans and Pricing	Patent Expiration:	May 29, 2022	Product Flag?	Y	Substance 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:	See Plans and Pricing	Patent Expiration:	Dec 26, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PARKINSON'S DISEASE
Patent:	See Plans and Pricing	Patent Expiration:	Dec 26, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION

Expired US Patents for NDA 203312

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-001	Jan 7, 2015	See Plans and Pricing	See Plans and Pricing
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-002	Jan 7, 2015	See Plans and Pricing	See Plans and Pricing
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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