Application 209410

Type: NDA
Sponsor: OSMOTICA PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OSMOLEX ER	AMANTADINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 129MG BASE	Yes	No
002	OSMOLEX ER	AMANTADINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 193MG BASE	Yes	No
003	OSMOLEX ER	AMANTADINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 258MG BASE	Yes	Yes
004	OSMOLEX ER	AMANTADINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 161MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N209410-001	OSMOLEX ER	AMANTADINE HYDROCHLORIDE	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16
N209410-002	OSMOLEX ER	AMANTADINE HYDROCHLORIDE	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16
N209410-003	OSMOLEX ER	AMANTADINE HYDROCHLORIDE	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16
N209410-004	OSMOLEX ER	AMANTADINE HYDROCHLORIDE	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22

Orange Book patents#

Current patent rows page 1 of 1 · 38 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209410-001	8389578	2028-01-22	U-219		2021-02-10
N209410-001	8389578	2028-01-22	U-3054		2021-02-10
N209410-001	8252331	2030-03-13		Drug product	2018-03-01
N209410-001	10213393	2038-02-15	U-20		2019-03-13
N209410-001	10213394	2038-02-15	U-2497		2019-03-13
N209410-001	10500170	2038-02-15	U-20		2019-12-17
N209410-001	10500171	2038-02-15	U-2497		2019-12-17
N209410-001	10500172	2038-02-15	U-2497		2019-12-17
N209410-001	10512617	2038-02-15	U-2497		2020-01-02
N209410-001	11890261	2038-02-15	U-2497		2024-03-04
N209410-002	8389578	2028-01-22	U-219		2021-02-10
N209410-002	8389578	2028-01-22	U-3054		2021-02-10
N209410-002	8252331	2030-03-13		Drug product	2018-03-01
N209410-002	10213393	2038-02-15	U-20		2019-03-13
N209410-002	10213394	2038-02-15	U-2497		2019-03-13
N209410-002	10500170	2038-02-15	U-20		2019-12-17
N209410-002	10500171	2038-02-15	U-2497		2019-12-17
N209410-002	10500172	2038-02-15	U-2497		2019-12-17
N209410-002	10512617	2038-02-15	U-2497		2020-01-02
N209410-002	11890261	2038-02-15	U-2497		2024-03-04
N209410-003	8389578	2028-01-22	U-219		2021-02-10
N209410-003	8389578	2028-01-22	U-3054		2021-02-10
N209410-003	8252331	2030-03-13		Drug product	2018-03-01
N209410-003	10213393	2038-02-15	U-20		2019-03-13
N209410-003	10213394	2038-02-15	U-2497		2019-03-13
N209410-003	10500170	2038-02-15	U-20		2019-12-17
N209410-003	10500171	2038-02-15	U-2497		2019-12-17
N209410-003	10500172	2038-02-15	U-2497		2019-12-17
N209410-003	10512617	2038-02-15	U-2497		2020-01-02
N209410-004	8389578	2028-01-22	U-219		2021-02-10
N209410-004	8389578	2028-01-22	U-3054		2021-02-10
N209410-004	8252331	2030-03-13		Drug product	2020-10-29
N209410-004	10213393	2038-02-15	U-20		2020-10-29
N209410-004	10213394	2038-02-15	U-2497		2020-10-29
N209410-004	10500170	2038-02-15	U-20		2020-10-29
N209410-004	10500171	2038-02-15	U-2497		2020-10-29
N209410-004	10500172	2038-02-15	U-2497		2020-10-29
N209410-004	10512617	2038-02-15	U-2497		2020-10-29

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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 90 · 3,584 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209410-001	8389578	2028-01-22	U-3054		2021-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-001	8389578	2028-01-22	U-219		2021-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-001	8252331	2030-03-13		Drug product	2018-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-001	10213393	2038-02-15	U-20		2019-03-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-001	10213394	2038-02-15	U-2497		2019-03-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-001	10500170	2038-02-15	U-20		2019-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-001	10500171	2038-02-15	U-2497		2019-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-001	10500172	2038-02-15	U-2497		2019-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-001	10512617	2038-02-15	U-2497		2020-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-001	11890261	2038-02-15	U-2497		2024-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-002	8389578	2028-01-22	U-219		2021-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-002	8389578	2028-01-22	U-3054		2021-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-002	8252331	2030-03-13		Drug product	2018-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-002	10213393	2038-02-15	U-20		2019-03-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-002	10213394	2038-02-15	U-2497		2019-03-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-002	10500170	2038-02-15	U-20		2019-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-002	10500171	2038-02-15	U-2497		2019-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-002	10500172	2038-02-15	U-2497		2019-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-002	10512617	2038-02-15	U-2497		2020-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-002	11890261	2038-02-15	U-2497		2024-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-003	8389578	2028-01-22	U-219		2021-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-003	8389578	2028-01-22	U-3054		2021-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-003	8252331	2030-03-13		Drug product	2018-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-003	10213393	2038-02-15	U-20		2019-03-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-003	10213394	2038-02-15	U-2497		2019-03-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-003	10500170	2038-02-15	U-20		2019-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-003	10500171	2038-02-15	U-2497		2019-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-003	10500172	2038-02-15	U-2497		2019-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-003	10512617	2038-02-15	U-2497		2020-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-004	8389578	2028-01-22	U-3054		2021-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-004	8389578	2028-01-22	U-219		2021-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-004	8252331	2030-03-13		Drug product	2020-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-004	10213393	2038-02-15	U-20		2020-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-004	10213394	2038-02-15	U-2497		2020-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-004	10500170	2038-02-15	U-20		2020-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-004	10500171	2038-02-15	U-2497		2020-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-004	10500172	2038-02-15	U-2497		2020-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209410-004	10512617	2038-02-15	U-2497		2020-10-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209410-001	8389578	2028-01-22	U-3054		2021-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209410-001	8389578	2028-01-22	U-219		2021-02-10	`caaa826d4ba7…`

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 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	BAJAJ MEDICAL, LLC	38fccce5-1f1e-9350-e063-6394a90a045a	2025-07-02	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
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

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 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68025-021	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-074	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-074	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-074	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-074	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-075	Osmolex ER	amantadine	Vertical Pharmaceuticals,	NDA	Current
68025-075	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-075	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-075	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-075	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-075	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-076	Osmolex ER	amantadine	Vertical Pharmaceuticals,	NDA	Current
68025-076	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-076	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-076	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-076	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-076	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-077	Osmolex ER	amantadine	Vertical Pharmaceuticals,	NDA	Current
68025-077	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-077	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-077	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-077	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
70482-075	OSMOLEX ER	amantadine	Adamas Pharma, LLC	NDA	Current
70482-075	OSMOLEX ER	amantadine	Adamas Pharma, LLC	NDA	Current
70482-075	OSMOLEX ER	amantadine	Adamas Pharma, LLC	NDA	Current
70482-076	OSMOLEX ER	amantadine	Adamas Pharma, LLC	NDA	Current
70482-076	OSMOLEX ER	amantadine	Adamas Pharma, LLC	NDA	Current
70482-076	OSMOLEX ER	amantadine	Adamas Pharma, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82815	SUPPL	2025-07-11
82792	SUPPL	2025-07-11
57037	ORIG	2018-12-26
52699	ORIG	2018-02-23
52687	ORIG	2018-02-22