Application 017555

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SINEMET	CARBIDOPA; LEVODOPA	TABLET;ORAL	10MG;100MG	Yes	No
002	SINEMET	CARBIDOPA; LEVODOPA	TABLET;ORAL	25MG;250MG	Yes	Yes
003	SINEMET	CARBIDOPA; LEVODOPA	TABLET;ORAL	25MG;100MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N017555-001	SINEMET	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982
N017555-002	SINEMET	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982
N017555-003	SINEMET	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N017555-001	AB
N017555-002	AB
N017555-003	AB

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 2 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N017555-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017555-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017555-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017555-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017555-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017555-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017555-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017555-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017555-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017555-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017555-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017555-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017555-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017555-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017555-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017555-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017555-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017555-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017555-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017555-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017555-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017555-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017555-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017555-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017555-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017555-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017555-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017555-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017555-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017555-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017555-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017555-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017555-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017555-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017555-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017555-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017555-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017555-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017555-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017555-001	AB	1	`301d65b070ca…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SINEMET	CARBIDOPA AND LEVODOPA	Organon LLC	9b17b028-964a-473c-823d-81423535bd66	2026-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017555 application number: NDA017555 ndc (product): 78206-166 ndc (product): 78206-168 ndc (product): 78206-167

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 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-3915	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-3915	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-3915	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-3915	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-3916	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-3916	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-3916	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-3916	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-3917	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-3917	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-3917	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-3917	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-6722	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-6722	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-6723	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-6723	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-6724	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
0006-6724	SINEMET	carbidopa and levodopa	Merck Sharp & Dohme Corp.	NDA	Current
78206-166	SINEMET	carbidopa and levodopa	Organon LLC	NDA	Current
78206-166	SINEMET	carbidopa and levodopa	Organon LLC	NDA	Current
78206-167	SINEMET	carbidopa and levodopa	Organon LLC	NDA	Current
78206-167	SINEMET	carbidopa and levodopa	Organon LLC	NDA	Current
78206-168	SINEMET	carbidopa and levodopa	Organon LLC	NDA	Current
78206-168	SINEMET	carbidopa and levodopa	Organon LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85492	SUPPL	2026-03-24
85439	SUPPL	2026-03-23
62881	SUPPL	2020-05-11
13845	SUPPL	2014-07-23
13842	SUPPL	2014-07-23
635	SUPPL	2014-07-23
33299	SUPPL	2014-07-22
11024	SUPPL	2014-07-22
11022	SUPPL	2014-07-22
40750	SUPPL	2013-06-03
13844	SUPPL	2011-02-07
11023	SUPPL	2011-02-04
33300	SUPPL	2009-01-06
13843	SUPPL	2009-01-06
13841	SUPPL	2001-04-11
13840	SUPPL	2001-04-11
13839	SUPPL	2001-04-11
13838	SUPPL	2001-04-11
634	SUPPL	2001-04-11
633	SUPPL	2001-04-11
632	SUPPL	2001-04-11
631	SUPPL	2001-04-11
630	SUPPL	2001-04-11