Application 019856

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SINEMET CR	CARBIDOPA; LEVODOPA	TABLET, EXTENDED RELEASE;ORAL	50MG;200MG	Yes	No
002	SINEMET CR	CARBIDOPA; LEVODOPA	TABLET, EXTENDED RELEASE;ORAL	25MG;100MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019856-001	SINEMET CR	CARBIDOPA; LEVODOPA	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1991-05-30
N019856-002	SINEMET CR	CARBIDOPA; LEVODOPA	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1992-12-24

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019856-001	SINEMET CR	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019856-002	SINEMET CR	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019856-001	SINEMET CR	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019856-002	SINEMET CR	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019856-001	SINEMET CR	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019856-002	SINEMET CR	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019856-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N019856-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019856-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019856-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019856-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019856-002	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-3918	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-3918	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-3919	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-3919	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85498	SUPPL	2026-03-24
85441	SUPPL	2026-03-23
19764	SUPPL	2014-07-23
19763	SUPPL	2014-07-23
1716	SUPPL	2014-07-23
34038	SUPPL	2014-07-22
34037	SUPPL	2014-07-22
11784	SUPPL	2014-07-22
1715	SUPPL	2011-02-07
34039	SUPPL	2011-02-04
19765	SUPPL	2009-01-06
11783	SUPPL	2009-01-06