Application 201971

Type: ANDA
Sponsor: MYLAN

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
A201971-001	RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB		2017-05-15
A201971-002	RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB		2017-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201971-001	AB
A201971-002	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	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`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	A201971-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201971-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201971-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201971-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201971-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201971-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201971-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201971-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201971-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201971-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201971-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201971-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201971-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201971-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201971-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201971-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201971-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201971-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201971-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201971-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201971-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201971-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201971-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201971-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201971-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201971-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201971-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201971-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201971-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201971-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201971-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201971-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201971-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201971-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201971-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201971-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201971-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201971-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201971-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201971-002	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rasagiline	RASAGILINE MESYLATE	Golden State Medical Supply, Inc.	4ee5cc48-7e1e-b268-e063-6394a90a5629	2026-05-07	Warnings, Adverse reactions	Name fallback generic name: RASAGILINE MESYLATE
Rasagiline mesylate	RASAGILINE MESYLATE	Florida Pharmaceutical Products, LLC	3b57a1c9-0ad9-40cf-a972-29851a658489	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: Rasagiline mesylate generic name: RASAGILINE MESYLATE
Rasagiline	RASAGILINE MESYLATE	Carnegie Pharmaceuticals LLC	e84da5ee-f93a-4e0e-9120-7dfcb9d18430	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: RASAGILINE MESYLATE
Rasagiline	RASAGILINE MESYLATE	Rising Pharma Holdings, Inc.	7d9eac3f-7441-45cf-a603-ea18c116e2c0	2025-07-11	Warnings, Adverse reactions	Name fallback generic name: RASAGILINE MESYLATE
Rasagiline	RASAGILINE MESYLATE	SKG Pharma Inc.	5c234b28-29e7-4149-9505-e2818a692bca	2025-04-04	Warnings, Adverse reactions	Name fallback generic name: RASAGILINE MESYLATE
Azilect	RASAGILINE MESYLATE	Teva Neuroscience, Inc.	a40d0e73-3f9f-4b01-979d-402c9cdaeb60	2020-06-30	Warnings, Adverse reactions	Name fallback generic name: RASAGILINE MESYLATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-1270	Rasagiline Mesylate	rasagiline mesylate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1270	Rasagiline Mesylate	rasagiline mesylate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1270	Rasagiline Mesylate	rasagiline mesylate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1270	Rasagiline Mesylate	rasagiline mesylate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1270	Rasagiline Mesylate	rasagiline mesylate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1271	Rasagiline Mesylate	rasagiline mesylate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1271	Rasagiline Mesylate	rasagiline mesylate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1271	Rasagiline Mesylate	rasagiline mesylate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1271	Rasagiline Mesylate	rasagiline mesylate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1271	Rasagiline Mesylate	rasagiline mesylate	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48402	ORIG	2017-05-17
48394	ORIG	2017-05-17