Application 208944

Type: NDA
Sponsor: ADAMAS PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GOCOVRI	AMANTADINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 68.5MG BASE	Yes	No
002	GOCOVRI	AMANTADINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 137MG 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
N208944-001	GOCOVRI	AMANTADINE HYDROCHLORIDE	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24
N208944-002	GOCOVRI	AMANTADINE HYDROCHLORIDE	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24

Orange Book patents#

Current patent rows page 1 of 1 · 34 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208944-001	8389578	2028-01-22	U-2105		2017-09-21
N208944-001	11197835	2030-12-02	U-2106		2022-01-12
N208944-001	8741343	2030-12-02	U-2106		2017-09-21
N208944-001	9867791	2030-12-02	U-2106		2018-01-16
N208944-001	9867792	2030-12-02	U-2106		2018-01-16
N208944-001	9867793	2030-12-02	U-2106		2018-01-16
N208944-001	9877933	2030-12-02	U-2224		2018-01-30
N208944-001	10646456	2034-06-17	U-2808		2020-07-14
N208944-001	11903908	2034-06-17	U-3822		2024-03-08
N208944-001	10154971	2034-12-04	U-2459		2018-12-18
N208944-001	11065213	2038-08-23		Drug product	2021-07-20
N208944-001	11077073	2038-08-23	U-2106		2021-08-04
N208944-001	11077073	2038-08-23	U-2224		2021-08-04
N208944-001	11077073	2038-08-23	U-3180		2021-08-04
N208944-001	12233033	2038-08-23	U-2106		2025-03-25
N208944-001	12233033	2038-08-23	U-2224		2025-03-25
N208944-001	12233033	2038-08-23	U-3180		2025-03-25
N208944-002	8389578	2028-01-22	U-2105		2017-09-21
N208944-002	11197835	2030-12-02	U-2106		2022-01-12
N208944-002	8741343	2030-12-02	U-2106		2017-09-21
N208944-002	9867791	2030-12-02	U-2106		2018-01-16
N208944-002	9867792	2030-12-02	U-2106		2018-01-16
N208944-002	9867793	2030-12-02	U-2106		2018-01-16
N208944-002	9877933	2030-12-02	U-2224		2018-01-30
N208944-002	10646456	2034-06-17	U-2808		2020-07-14
N208944-002	11903908	2034-06-17	U-3822		2024-03-08
N208944-002	10154971	2034-12-04	U-2459		2018-12-18
N208944-002	11065213	2038-08-23		Drug product	2021-07-20
N208944-002	11077073	2038-08-23	U-2106		2021-08-04
N208944-002	11077073	2038-08-23	U-2224		2021-08-04
N208944-002	11077073	2038-08-23	U-3180		2021-08-04
N208944-002	12233033	2038-08-23	U-2106		2025-03-25
N208944-002	12233033	2038-08-23	U-2224		2025-03-25
N208944-002	12233033	2038-08-23	U-3180		2025-03-25

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	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2017-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2017-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2017-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2017-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2017-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2017-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2017-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208944-001	GOCOVRI	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2017-08-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208944-002	GOCOVRI	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2017-08-24	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208944-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208944-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208944-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208944-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208944-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208944-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208944-001	AB	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 42 · 1,678 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N208944-001	8389578	2028-01-22	U-2105		2017-09-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	11197835	2030-12-02	U-2106		2022-01-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	8741343	2030-12-02	U-2106		2017-09-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	9867791	2030-12-02	U-2106		2018-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	9867792	2030-12-02	U-2106		2018-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	9867793	2030-12-02	U-2106		2018-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	9877933	2030-12-02	U-2224		2018-01-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	10646456	2034-06-17	U-2808		2020-07-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	11903908	2034-06-17	U-3822		2024-03-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	10154971	2034-12-04	U-2459		2018-12-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	11065213	2038-08-23		Drug product	2021-07-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	11077073	2038-08-23	U-2106		2021-08-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	11077073	2038-08-23	U-2224		2021-08-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	11077073	2038-08-23	U-3180		2021-08-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	12233033	2038-08-23	U-2106		2025-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	12233033	2038-08-23	U-3180		2025-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-001	12233033	2038-08-23	U-2224		2025-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	8389578	2028-01-22	U-2105		2017-09-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	11197835	2030-12-02	U-2106		2022-01-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	8741343	2030-12-02	U-2106		2017-09-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	9867791	2030-12-02	U-2106		2018-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	9867792	2030-12-02	U-2106		2018-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	9867793	2030-12-02	U-2106		2018-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	9877933	2030-12-02	U-2224		2018-01-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	10646456	2034-06-17	U-2808		2020-07-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	11903908	2034-06-17	U-3822		2024-03-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	10154971	2034-12-04	U-2459		2018-12-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	11065213	2038-08-23		Drug product	2021-07-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	11077073	2038-08-23	U-2224		2021-08-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	11077073	2038-08-23	U-3180		2021-08-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	11077073	2038-08-23	U-2106		2021-08-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	12233033	2038-08-23	U-2224		2025-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	12233033	2038-08-23	U-2106		2025-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208944-002	12233033	2038-08-23	U-3180		2025-03-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208944-001	8389578	2028-01-22	U-2105		2017-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208944-001	11197835	2030-12-02	U-2106		2022-01-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208944-001	8741343	2030-12-02	U-2106		2017-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208944-001	9867791	2030-12-02	U-2106		2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208944-001	9867792	2030-12-02	U-2106		2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208944-001	9867793	2030-12-02	U-2106		2018-01-16	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208944-001	ODE-153	2024-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208944-002	ODE-153	2024-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208944-001	ODE-153	2024-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208944-002	ODE-153	2024-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208944-001	ODE-153	2024-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208944-002	ODE-153	2024-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208944-001	ODE-153	2024-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208944-002	ODE-153	2024-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208944-001	ODE-153	2024-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208944-002	ODE-153	2024-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208944-001	ODE-153	2024-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208944-002	ODE-153	2024-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208944-001	ODE-153	2024-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208944-002	ODE-153	2024-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208944-001	ODE-153	2024-08-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208944-002	ODE-153	2024-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208944-001	ODE-153	2024-08-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208944-002	ODE-153	2024-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208944-001	ODE-153	2024-08-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208944-002	ODE-153	2024-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208944-001	ODE-153	2024-08-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208944-002	ODE-153	2024-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208944-001	ODE-153	2024-08-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208944-002	ODE-153	2024-08-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208944-001	I-769	2020-08-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208944-001	ODE-153	2024-08-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208944-002	I-769	2020-08-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208944-002	ODE-153	2024-08-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208944-001	ODE-153	2024-08-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208944-002	ODE-153	2024-08-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208944-001	ODE-153	2024-08-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208944-002	ODE-153	2024-08-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208944-001	ODE-153	2024-08-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208944-002	ODE-153	2024-08-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208944-001	ODE-153	2024-08-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208944-002	ODE-153	2024-08-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208944-001	I-769	2020-08-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208944-001	ODE-153	2024-08-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208944-002	I-769	2020-08-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208944-002	ODE-153	2024-08-24	`8869cabd3fbd…`

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 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	e3eb34af-6e25-4a3d-a7d2-e9a789e335cc	2025-06-26	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine HCl	AMANTADINE HYDROCHLORIDE	AvPAK	461e6444-189e-62ed-6c61-1c36a04459c6	2025-06-24	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine HCl	AMANTADINE HYDROCHLORIDE	AvKARE	bfd129ae-8b0a-f118-b7d0-45d106290b63	2025-06-24	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine HCl	AMANTADINE HYDROCHLORIDE	Bionpharma Inc.	d6ca4d20-72c5-496c-9ac7-1f5cb407a742	2025-06-09	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	EPIC PHARMA LLC	0f70c79a-92a4-4a38-bbdd-900adc4c2e93	2025-06-06	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	1b9498b7-125e-4314-baca-b62af6e5511c	2025-06-06	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	6fd54e00-a714-4442-af95-2515ab3b2ac3	2025-06-04	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	609dc911-1e9d-4ebd-b64b-f44054e5582e	2025-06-04	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Zydus Lifesciences Limited	579e6c23-6286-4b80-88de-c86c0e5cc2b2	2025-06-04	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	6311b46b-23cc-40c1-93c2-f7c92606386f	2025-05-12	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Coupler LLC	2d94073b-c064-c280-e063-6294a90af145	2025-02-07	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Proficient Rx LP	a3810649-1301-4332-85df-722b36867b1b	2025-02-01	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Coupler LLC	2cb6e83d-e635-b150-e063-6294a90ad61d	2025-01-27	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	1f3c7c37-c488-4a88-8251-7db52dc03827	2024-11-04	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Chartwell RX, LLC	a016ab57-d18f-4a3b-b2ab-f91fecc1eef7	2024-10-10	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	b54064bc-b3e1-4d83-be40-fcaddd2e99d0	2024-08-05	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Patrin Pharma, Inc.	0fcf5182-a666-4f38-879f-47f19de30dd5	2024-05-20	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	American Health Packaging	5a8f16cc-e5d5-4097-8297-10c8166c7a0e	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Strides Pharma Science Limited	20dad861-6ad1-4660-b315-8af57b294175	2023-07-17	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Proficient Rx LP	743d1b73-f47e-4bbf-bb52-45b1e7f17308	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70482-085	GOCOVRI	AMANTADINE	Adamas Pharma, LLC	NDA	Current
70482-085	GOCOVRI	AMANTADINE	Adamas Pharma, LLC	NDA	Current
70482-085	GOCOVRI	AMANTADINE	Adamas Pharma, LLC	NDA	Current
70482-085	GOCOVRI	AMANTADINE	Adamas Pharma, LLC	NDA	Current
70482-085	GOCOVRI	AMANTADINE	Adamas Pharma, LLC	NDA	Current
70482-170	GOCOVRI	AMANTADINE	Adamas Pharma, LLC	NDA	Current
70482-170	GOCOVRI	AMANTADINE	Adamas Pharma, LLC	NDA	Current
70482-170	GOCOVRI	AMANTADINE	Adamas Pharma, LLC	NDA	Current
70482-170	GOCOVRI	AMANTADINE	Adamas Pharma, LLC	NDA	Current
70482-170	GOCOVRI	AMANTADINE	Adamas Pharma, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82814	SUPPL	2025-07-11
82791	SUPPL	2025-07-11
66076	SUPPL	2021-02-03
66058	SUPPL	2021-02-02
62115	SUPPL	2020-03-11
62128	SUPPL	2020-03-10
54735	ORIG	2018-07-02
49540	ORIG	2017-08-25
49536	ORIG	2017-08-25