Application 201889

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RASAGILINE MESYLATE	RASAGILINE MESYLATE	TABLET;ORAL	EQ 0.5MG BASE	No	No
002	RASAGILINE MESYLATE	RASAGILINE MESYLATE	TABLET;ORAL	EQ 1MG BASE	No	No

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

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
A201889-001	RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB		2017-10-30
A201889-002	RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB		2017-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A201889-001	AB
A201889-002	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 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201889-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201889-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201889-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201889-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201889-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201889-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201889-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201889-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201889-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201889-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201889-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201889-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201889-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201889-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201889-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201889-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201889-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201889-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201889-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201889-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201889-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201889-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201889-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201889-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201889-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201889-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201889-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201889-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201889-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201889-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201889-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201889-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201889-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201889-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201889-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201889-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201889-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201889-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201889-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201889-002	AB	1	`782e0a99824c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rasagiline	RASAGILINE	REMEDYREPACK INC.	fdebcedc-1b5e-4803-9617-58d705cda726	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201889 application number: ANDA201889
Rasagiline	RASAGILINE	NorthStar RxLLC	8bf8e76c-27cb-42a4-aa9c-bdade68c463b	2023-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201889 application number: ANDA201889 ndc (product): 16714-770 ndc (product): 16714-771
Rasagiline	RASAGILINE	Ascend Laboratories, LLC	5dfeec8f-f4f3-4e06-915e-3244467516a6	2022-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201889 application number: ANDA201889 ndc (product): 67877-260 ndc (product): 67877-259

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-770	Rasagiline	Rasagiline	NorthStar RxLLC	ANDA	Current
16714-770	Rasagiline	Rasagiline	NorthStar RxLLC	ANDA	Current
16714-771	Rasagiline	Rasagiline	NorthStar RxLLC	ANDA	Current
16714-771	Rasagiline	Rasagiline	NorthStar RxLLC	ANDA	Current
67877-259	Rasagiline	Rasagiline	Ascend Laboratories, LLC	ANDA	Current
67877-259	Rasagiline	Rasagiline	Ascend Laboratories, LLC	ANDA	Current
67877-259	Rasagiline	Rasagiline	Ascend Laboratories, LLC	ANDA	Current
67877-259	Rasagiline	Rasagiline	Ascend Laboratories, LLC	ANDA	Current
67877-260	Rasagiline	Rasagiline	Ascend Laboratories, LLC	ANDA	Current
67877-260	Rasagiline	Rasagiline	Ascend Laboratories, LLC	ANDA	Current
67877-260	Rasagiline	Rasagiline	Ascend Laboratories, LLC	ANDA	Current
67877-260	Rasagiline	Rasagiline	Ascend Laboratories, LLC	ANDA	Current