Application 021641

Type: NDA
Sponsor: TEVA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N021641-001	AZILECT	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16
N021641-002	AZILECT	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021641-001	AB
N021641-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021641-001	7572834	2026-12-05		Drug product
N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08
N021641-002	7572834	2026-12-05		Drug product
N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N021641-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021641-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021641-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021641-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021641-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021641-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021641-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021641-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021641-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021641-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021641-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021641-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021641-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021641-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021641-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021641-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021641-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021641-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021641-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021641-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021641-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021641-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021641-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021641-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021641-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021641-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021641-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021641-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021641-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021641-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021641-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021641-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021641-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021641-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021641-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021641-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021641-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021641-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021641-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021641-002	AB	1	`4b0b4de00fa7…`

Observed Orange Book patent history#

Patent history page 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021641-001	7572834	2026-12-05		Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021641-002	7572834	2026-12-05		Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021641-001	7572834	2026-12-05		Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021641-002	7572834	2026-12-05		Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021641-001	7572834	2026-12-05		Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021641-002	7572834	2026-12-05		Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021641-001	7572834	2026-12-05		Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021641-002	7572834	2026-12-05		Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021641-001	7572834	2026-12-05		Drug product		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021641-002	7572834	2026-12-05		Drug product		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021641-001	7572834	2026-12-05		Drug product		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021641-002	7572834	2026-12-05		Drug product		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021641-001	7572834	2026-12-05		Drug product		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021641-002	7572834	2026-12-05		Drug product		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021641-001	7572834	2026-12-05		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021641-002	7572834	2026-12-05		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021641-001	7572834	2026-12-05		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021641-002	7572834	2026-12-05		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021641-001	7572834	2026-12-05		Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021641-002	7572834	2026-12-05		Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`4b0b4de00fa7…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azilect	RASAGILINE MESYLATE	Teva Neuroscience, Inc.	a40d0e73-3f9f-4b01-979d-402c9cdaeb60	2020-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021641 application number: NDA021641 ndc (product): 68546-142 ndc (product): 68546-229
Rasagiline	RASAGILINE	Teva Pharmaceuticals USA, Inc.	e802c83c-e581-4a11-b83d-1df47120078d	2020-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021641 application number: NDA021641 ndc (product): 0093-3060 ndc (product): 0093-3061

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 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-3060	Rasagiline	Rasagiline	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3060	Rasagiline	Rasagiline	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3060	Rasagiline	Rasagiline	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3060	Rasagiline	Rasagiline	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3060	Rasagiline	Rasagiline	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3060	Rasagiline	Rasagiline	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3060	Rasagiline	Rasagiline	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3060	Rasagiline	Rasagiline	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3061	Rasagiline	Rasagiline	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3061	Rasagiline	Rasagiline	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3061	Rasagiline	Rasagiline	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3061	Rasagiline	Rasagiline	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3061	Rasagiline	Rasagiline	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3061	Rasagiline	Rasagiline	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3061	Rasagiline	Rasagiline	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3061	Rasagiline	Rasagiline	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
42291-779	Rasagiline	Rasagiline	AvKARE	NDA AUTHORIZED GENERIC	Current
42291-779	Rasagiline	Rasagiline	AvKARE	NDA AUTHORIZED GENERIC	Current
42291-780	Rasagiline	Rasagiline	AvKARE	NDA AUTHORIZED GENERIC	Current
42291-780	Rasagiline	Rasagiline	AvKARE	NDA AUTHORIZED GENERIC	Current
43353-015	Azilect	Rasagiline Mesylate	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
68546-142	Azilect	Rasagiline mesylate	Teva Neuroscience, Inc.	NDA	Current
68546-142	Azilect	Rasagiline mesylate	Teva Neuroscience, Inc.	NDA	Current
68546-142	Azilect	Rasagiline mesylate	Teva Neuroscience, Inc.	NDA	Current
68546-142	Azilect	Rasagiline mesylate	Teva Neuroscience, Inc.	NDA	Current
68546-142	Azilect	Rasagiline mesylate	Teva Neuroscience, Inc.	NDA	Current
68546-142	Azilect	Rasagiline mesylate	Teva Neuroscience, Inc.	NDA	Current
68546-142	Azilect	Rasagiline mesylate	Teva Neuroscience, Inc.	NDA	Current
68546-229	Azilect	Rasagiline mesylate	Teva Neuroscience, Inc.	NDA	Current
68546-229	Azilect	Rasagiline mesylate	Teva Neuroscience, Inc.	NDA	Current
68546-229	Azilect	Rasagiline mesylate	Teva Neuroscience, Inc.	NDA	Current
68546-229	Azilect	Rasagiline mesylate	Teva Neuroscience, Inc.	NDA	Current
68546-229	Azilect	Rasagiline mesylate	Teva Neuroscience, Inc.	NDA	Current
68546-229	Azilect	Rasagiline mesylate	Teva Neuroscience, Inc.	NDA	Current
68546-229	Azilect	Rasagiline mesylate	Teva Neuroscience, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63599	SUPPL	2020-06-17
63593	SUPPL	2020-06-17
56979	SUPPL	2018-12-21
5904	SUPPL	2014-06-02
5903	SUPPL	2014-06-02
37386	SUPPL	2014-05-30
15913	SUPPL	2014-05-30
28298	SUPPL	2010-01-26
28297	SUPPL	2010-01-26
28296	SUPPL	2010-01-26
28295	SUPPL	2010-01-26
28294	SUPPL	2010-01-26
5902	SUPPL	2010-01-26
5901	SUPPL	2010-01-26
42246	SUPPL	2010-01-22
24207	SUPPL	2010-01-22
37385	SUPPL	2009-12-10
37384	SUPPL	2009-12-10
37383	SUPPL	2009-12-10
37382	SUPPL	2009-12-10
15912	SUPPL	2009-12-10
15911	SUPPL	2009-12-10
15910	SUPPL	2009-12-10
21765	ORIG	2006-07-24
5900	ORIG	2006-05-21
37381	ORIG	2006-05-18