Application 203312

Type: NDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RYTARY	CARBIDOPA; LEVODOPA	CAPSULE, EXTENDED RELEASE;ORAL	23.75MG;95MG	Yes	No
002	RYTARY	CARBIDOPA; LEVODOPA	CAPSULE, EXTENDED RELEASE;ORAL	36.25MG;145MG	Yes	No
003	RYTARY	CARBIDOPA; LEVODOPA	CAPSULE, EXTENDED RELEASE;ORAL	48.75MG;195MG	Yes	No
004	RYTARY	CARBIDOPA; LEVODOPA	CAPSULE, EXTENDED RELEASE;ORAL	61.25MG;245MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64896-661	RYTARY	Levodopa and Carbidopa	Amneal Pharmaceuticals LLC	NDA	Current
64896-661	RYTARY	Levodopa and Carbidopa	Amneal Pharmaceuticals LLC	NDA	Current
64896-661	RYTARY	Levodopa and Carbidopa	Amneal Pharmaceuticals LLC	NDA	Current
64896-661	RYTARY	Levodopa and Carbidopa	Impax Specialty Pharma	NDA	Current
64896-661	RYTARY	Levodopa and Carbidopa	Amneal Pharmaceuticals LLC	NDA	Current
64896-662	RYTARY	Levodopa and Carbidopa	Amneal Pharmaceuticals LLC	NDA	Current
64896-662	RYTARY	Levodopa and Carbidopa	Amneal Pharmaceuticals LLC	NDA	Current
64896-662	RYTARY	Levodopa and Carbidopa	Amneal Pharmaceuticals LLC	NDA	Current
64896-662	RYTARY	Levodopa and Carbidopa	Amneal Pharmaceuticals LLC	NDA	Current
64896-662	RYTARY	Levodopa and Carbidopa	Impax Specialty Pharma	NDA	Current
64896-663	RYTARY	Levodopa and Carbidopa	Amneal Pharmaceuticals LLC	NDA	Current
64896-663	RYTARY	Levodopa and Carbidopa	Impax Specialty Pharma	NDA	Current
64896-663	RYTARY	Levodopa and Carbidopa	Amneal Pharmaceuticals LLC	NDA	Current
64896-663	RYTARY	Levodopa and Carbidopa	Amneal Pharmaceuticals LLC	NDA	Current
64896-663	RYTARY	Levodopa and Carbidopa	Amneal Pharmaceuticals LLC	NDA	Current
64896-664	RYTARY	Levodopa and Carbidopa	Amneal Pharmaceuticals LLC	NDA	Current
64896-664	RYTARY	Levodopa and Carbidopa	Amneal Pharmaceuticals LLC	NDA	Current
64896-664	RYTARY	Levodopa and Carbidopa	Amneal Pharmaceuticals LLC	NDA	Current
64896-664	RYTARY	Levodopa and Carbidopa	Amneal Pharmaceuticals LLC	NDA	Current
64896-664	RYTARY	Levodopa and Carbidopa	Impax Specialty Pharma	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85496	SUPPL	2026-03-24
85448	SUPPL	2026-03-23
61362	SUPPL	2019-12-20
61328	SUPPL	2019-12-18
48468	SUPPL	2017-05-19
45733	SUPPL	2016-10-31
44881	ORIG	2016-06-15
43426	ORIG	2016-06-15
40286	ORIG	2015-01-08
32407	ORIG	2015-01-08

Application 203312

Related Records#

Application Products#

NDC Listings For This Application#

Documents#