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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N203312-001	RYTARY	CARBIDOPA; LEVODOPA	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07
N203312-002	RYTARY	CARBIDOPA; LEVODOPA	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07
N203312-003	RYTARY	CARBIDOPA; LEVODOPA	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07
N203312-004	RYTARY	CARBIDOPA; LEVODOPA	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07

Orange Book patents#

Current patent rows page 1 of 1 · 60 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203312-001	8377474	2028-12-26	U-1645	Drug product	2015-01-27
N203312-001	8377474	2028-12-26	U-219	Drug product	2015-01-27
N203312-001	8454998	2028-12-26	U-1645	Drug product	2015-01-27
N203312-001	8454998	2028-12-26	U-1646	Drug product	2015-01-27
N203312-001	8454998	2028-12-26	U-1647	Drug product	2015-01-27
N203312-001	8454998	2028-12-26	U-1649	Drug product	2015-01-27
N203312-001	8454998	2028-12-26	U-219	Drug product	2015-01-27
N203312-001	8557283	2028-12-26	U-1645	Drug product	2015-01-27
N203312-001	8557283	2028-12-26	U-219	Drug product	2015-01-27
N203312-001	9089607	2028-12-26	U-1645	Drug product	2015-08-10
N203312-001	9089607	2028-12-26	U-1720	Drug product	2015-08-10
N203312-001	9089608	2028-12-26		Drug product	2015-08-10
N203312-001	9463246	2028-12-26	U-219	Drug product	2016-10-12
N203312-001	9533046	2028-12-26	U-219	Drug product	2017-01-11
N203312-001	9901640	2028-12-26	U-219	Drug product	2018-02-28
N203312-002	8377474	2028-12-26	U-1645	Drug product	2015-01-27
N203312-002	8377474	2028-12-26	U-219	Drug product	2015-01-27
N203312-002	8454998	2028-12-26	U-1645	Drug product	2015-01-27
N203312-002	8454998	2028-12-26	U-1646	Drug product	2015-01-27
N203312-002	8454998	2028-12-26	U-1647	Drug product	2015-01-27
N203312-002	8454998	2028-12-26	U-1649	Drug product	2015-01-27
N203312-002	8454998	2028-12-26	U-219	Drug product	2015-01-27
N203312-002	8557283	2028-12-26	U-1645	Drug product	2015-01-27
N203312-002	8557283	2028-12-26	U-219	Drug product	2015-01-27
N203312-002	9089607	2028-12-26	U-1645	Drug product	2015-08-10
N203312-002	9089607	2028-12-26	U-1720	Drug product	2015-08-10
N203312-002	9089608	2028-12-26		Drug product	2015-08-10
N203312-002	9463246	2028-12-26	U-219	Drug product	2016-10-12
N203312-002	9533046	2028-12-26	U-219	Drug product	2017-01-11
N203312-002	9901640	2028-12-26	U-219	Drug product	2018-02-28
N203312-003	8377474	2028-12-26	U-1645	Drug product	2015-01-27
N203312-003	8377474	2028-12-26	U-219	Drug product	2015-01-27
N203312-003	8454998	2028-12-26	U-1645	Drug product	2015-01-27
N203312-003	8454998	2028-12-26	U-1646	Drug product	2015-01-27
N203312-003	8454998	2028-12-26	U-1647	Drug product	2015-01-27
N203312-003	8454998	2028-12-26	U-1649	Drug product	2015-01-27
N203312-003	8454998	2028-12-26	U-219	Drug product	2015-01-27
N203312-003	8557283	2028-12-26	U-1645	Drug product	2015-01-27
N203312-003	8557283	2028-12-26	U-219	Drug product	2015-01-27
N203312-003	9089607	2028-12-26	U-1645	Drug product	2015-08-10
N203312-003	9089607	2028-12-26	U-1720	Drug product	2015-08-10
N203312-003	9089608	2028-12-26		Drug product	2015-08-10
N203312-003	9463246	2028-12-26	U-219	Drug product	2016-10-12
N203312-003	9533046	2028-12-26	U-219	Drug product	2017-01-11
N203312-003	9901640	2028-12-26	U-219	Drug product	2018-02-28
N203312-004	8377474	2028-12-26	U-1645	Drug product	2015-01-27
N203312-004	8377474	2028-12-26	U-219	Drug product	2015-01-27
N203312-004	8454998	2028-12-26	U-1645	Drug product	2015-01-27
N203312-004	8454998	2028-12-26	U-1646	Drug product	2015-01-27
N203312-004	8454998	2028-12-26	U-1647	Drug product	2015-01-27
N203312-004	8454998	2028-12-26	U-1649	Drug product	2015-01-27
N203312-004	8454998	2028-12-26	U-219	Drug product	2015-01-27
N203312-004	8557283	2028-12-26	U-1645	Drug product	2015-01-27
N203312-004	8557283	2028-12-26	U-219	Drug product	2015-01-27
N203312-004	9089607	2028-12-26	U-1645	Drug product	2015-08-10
N203312-004	9089607	2028-12-26	U-1720	Drug product	2015-08-10
N203312-004	9089608	2028-12-26		Drug product	2015-08-10
N203312-004	9463246	2028-12-26	U-219	Drug product	2016-10-12
N203312-004	9533046	2028-12-26	U-219	Drug product	2017-01-11
N203312-004	9901640	2028-12-26	U-219	Drug product	2018-02-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 64 · 2,532 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203312-001	8377474	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	8377474	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	8454998	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	8454998	2028-12-26	U-1649	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	8454998	2028-12-26	U-1646	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	8454998	2028-12-26	U-1647	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	8454998	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	8557283	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	8557283	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	9089607	2028-12-26	U-1645	Drug product	2015-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	9089607	2028-12-26	U-1720	Drug product	2015-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	9089608	2028-12-26		Drug product	2015-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	9463246	2028-12-26	U-219	Drug product	2016-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	9533046	2028-12-26	U-219	Drug product	2017-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	9901640	2028-12-26	U-219	Drug product	2018-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8377474	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8377474	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8454998	2028-12-26	U-1649	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8454998	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8454998	2028-12-26	U-1647	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8454998	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8454998	2028-12-26	U-1646	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8557283	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8557283	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	9089607	2028-12-26	U-1645	Drug product	2015-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	9089607	2028-12-26	U-1720	Drug product	2015-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	9089608	2028-12-26		Drug product	2015-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	9463246	2028-12-26	U-219	Drug product	2016-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	9533046	2028-12-26	U-219	Drug product	2017-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	9901640	2028-12-26	U-219	Drug product	2018-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8377474	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8377474	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8454998	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8454998	2028-12-26	U-1647	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8454998	2028-12-26	U-1649	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8454998	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8454998	2028-12-26	U-1646	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8557283	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8557283	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	9089607	2028-12-26	U-1645	Drug product	2015-08-10	`011fe1cb6892…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	REMEDYREPACK INC.	4ce99f65-5857-448c-b22a-9b3b64de69e2	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203312 application number: NDA203312
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	REMEDYREPACK INC.	b29e58f0-67b1-4036-a4a8-4915a8c13cdf	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203312 application number: NDA203312
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	REMEDYREPACK INC.	beedd327-bbc5-4f17-838a-4e72bf0867f0	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203312 application number: NDA203312
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	REMEDYREPACK INC.	9ac804f1-7e15-48bc-8ae9-25181a629dd4	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203312 application number: NDA203312
RYTARY	CARBIDOPA AND LEVODOPA	Amneal Pharmaceuticals LLC	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203312 application number: NDA203312 ndc (product): 64896-661 ndc (product): 64896-662 ndc (product): 64896-663 ndc (product): 64896-664
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Zydus Pharmaceuticals USA Inc.	74e7f96b-de31-4e3c-b32d-11421b291d4e	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203312 application number: NDA203312

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

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	Amneal Pharmaceuticals LLC	NDA	Current
64896-661	RYTARY	Levodopa and Carbidopa	Impax Specialty Pharma	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	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
64896-663	RYTARY	Levodopa and Carbidopa	Impax Specialty Pharma	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