Application 019334

Type: NDA
Sponsor: SOMERSET

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SELEGILINE HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019334-001	SELEGILINE HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1989-06-05

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019334-001	SELEGILINE HYDROCHLORIDE	5MG	TABLET / ORAL	RLD	1989-06-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019334-001	SELEGILINE HYDROCHLORIDE	5MG	TABLET / ORAL	RLD	1989-06-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-06-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-06-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-06-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-06-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-06-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-06-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-06-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-06-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-06-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019334-001	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-06-05	`f41ea6bd6efb…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	040a97e5-efd1-4a2f-b737-2f13e5366d70	2025-11-24	Warnings, Adverse reactions	Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	df88d6bf-0fda-3825-e053-2a95a90a3a75	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	Bryant Ranch Prepack	b8eb0a00-adc7-4aaf-987c-fa1b207b2996	2025-08-18	Warnings, Adverse reactions	Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	Bryant Ranch Prepack	4848270a-1179-410c-b4e6-a7e555b3a988	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	A2A Integrated Pharmaceuticals	a59ff47b-4379-44f3-9d2c-f8c6121d1881	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	23c4481f-d150-40c6-addb-b3e454ca914f	2024-08-07	Warnings, Adverse reactions	Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	Chartwell RX, LLC	189ac32d-28b4-47c5-9de6-318e502eff3b	2024-05-08	Warnings, Adverse reactions	Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	i3 Pharmaceuticals, LLC	c81e983b-455d-2e65-e053-2a95a90a3123	2024-03-20	Warnings, Adverse reactions	Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	A-S Medication Solutions	f286c854-3b8c-44a8-b3b5-c828dbabb207	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	Proficient Rx LP	57b564ef-c89b-4cf6-a11f-f67391d74e7e	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE
ZELAPAR	SELEGILINE HYDROCHLORIDE	Bausch Health US, LLC	380d7717-2a79-42f3-a712-efe5e7696ba0	2021-06-01	Warnings, Adverse reactions	Name fallback generic name: SELEGILINE HYDROCHLORIDE
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	Novitium Pharma LLC	e42d99b0-c62e-49d4-b792-1301bb539b92	2021-04-01	Warnings, Adverse reactions	Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
33725	SUPPL	2009-01-06
33724	SUPPL	2009-01-06
1287	SUPPL	2009-01-06
1286	SUPPL	2009-01-06