Application 021479

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZELAPAR	SELEGILINE HYDROCHLORIDE	TABLET, ORALLY DISINTEGRATING;ORAL	1.25MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021479-001	ZELAPAR	SELEGILINE HYDROCHLORIDE	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD, RS	2006-06-14

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`e64feba35796…`

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
ZELAPAR	SELEGILINE HYDROCHLORIDE	Bausch Health US, LLC	380d7717-2a79-42f3-a712-efe5e7696ba0	2021-06-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021479 application number: NDA021479 ndc (product): 0187-0453

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-0453	ZELAPAR	SELEGILINE HYDROCHLORIDE	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0453	ZELAPAR	SELEGILINE HYDROCHLORIDE	Bausch Health US, LLC	NDA	Current
0187-0453	ZELAPAR	SELEGILINE HYDROCHLORIDE	Bausch Health US, LLC	NDA	Current
0187-0453	ZELAPAR	SELEGILINE HYDROCHLORIDE	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0453	ZELAPAR	SELEGILINE HYDROCHLORIDE	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0453	ZELAPAR	SELEGILINE HYDROCHLORIDE	Bausch Health US, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67838	SUPPL	2021-06-17
67836	SUPPL	2021-06-17
59753	SUPPL	2019-08-20
15566	SUPPL	2014-08-19
5497	SUPPL	2014-08-01
21684	ORIG	2009-01-15
37035	SUPPL	2009-01-06
27897	SUPPL	2009-01-06
15565	SUPPL	2009-01-06
5496	SUPPL	2009-01-06
27896	ORIG	2006-06-20
15564	ORIG	2006-06-20