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 1.

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 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209410-001	OSMOLEX ER	EQ 129MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209410-002	OSMOLEX ER	EQ 193MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209410-003	OSMOLEX ER	EQ 258MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209410-004	OSMOLEX ER	EQ 161MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-04-22	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 88 · 3,508 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209410-001	8389578	2028-01-22	U-3054		2021-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-001	8389578	2028-01-22	U-219		2021-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-001	8252331	2030-03-13		Drug product	2018-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-001	10213393	2038-02-15	U-20		2019-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-001	10213394	2038-02-15	U-2497		2019-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-001	10500170	2038-02-15	U-20		2019-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-001	10500171	2038-02-15	U-2497		2019-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-001	10500172	2038-02-15	U-2497		2019-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-001	10512617	2038-02-15	U-2497		2020-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-001	11890261	2038-02-15	U-2497		2024-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-002	8389578	2028-01-22	U-219		2021-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-002	8389578	2028-01-22	U-3054		2021-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-002	8252331	2030-03-13		Drug product	2018-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-002	10213393	2038-02-15	U-20		2019-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-002	10213394	2038-02-15	U-2497		2019-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-002	10500170	2038-02-15	U-20		2019-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-002	10500171	2038-02-15	U-2497		2019-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-002	10500172	2038-02-15	U-2497		2019-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-002	10512617	2038-02-15	U-2497		2020-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-002	11890261	2038-02-15	U-2497		2024-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-003	8389578	2028-01-22	U-219		2021-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-003	8389578	2028-01-22	U-3054		2021-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-003	8252331	2030-03-13		Drug product	2018-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-003	10213393	2038-02-15	U-20		2019-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-003	10213394	2038-02-15	U-2497		2019-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-003	10500170	2038-02-15	U-20		2019-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-003	10500171	2038-02-15	U-2497		2019-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-003	10500172	2038-02-15	U-2497		2019-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-003	10512617	2038-02-15	U-2497		2020-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-004	8389578	2028-01-22	U-3054		2021-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-004	8389578	2028-01-22	U-219		2021-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-004	8252331	2030-03-13		Drug product	2020-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-004	10213393	2038-02-15	U-20		2020-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-004	10213394	2038-02-15	U-2497		2020-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-004	10500170	2038-02-15	U-20		2020-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-004	10500171	2038-02-15	U-2497		2020-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-004	10500172	2038-02-15	U-2497		2020-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209410-004	10512617	2038-02-15	U-2497		2020-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209410-001	8796337	2025-11-23	U-219		2021-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209410-001	8796337	2025-11-23	U-3054		2021-02-10	`31067a03dcf5…`

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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	AvKARE	547904f3-84a3-1ccb-e063-6294a90a6fb6	2026-06-17	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	A-S Medication Solutions	da693bb0-0cc8-485d-89a7-c8cf28d440f3	2026-05-15	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	6326d7f5-4c7c-4541-8db1-c582f1525f60	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	Cardinal Health 107, LLC	5989098d-2855-4b5f-9a06-64a83656c078	2026-04-08	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	Zhejiang Jutai Pharmaceutical Co., Ltd.	9c5e0c61-372b-4d1b-8882-e13f6af8fed0	2026-03-26	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Strides Pharma Inc.	e4d8f36f-d668-4728-8dca-b1c22bd9aedb	2026-01-30	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Major Pharmaceuticals	b2f7da34-ad78-4db3-9af1-bdd341e09f16	2026-01-05	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Chartwell Governmental & Specialty RX, LLC.	3c448cb3-7996-4a83-a9ad-23a00a431fbe	2025-12-19	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Strides Pharma Inc.	9a99bb98-82a4-4b9e-9216-554dade72a3c	2025-12-12	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Chartwell RX, LLC	52aa093c-82cc-4d81-b072-86a2b8adc9c5	2025-12-12	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	63d9d4aa-5f92-45b0-98d0-d6ec38b727cb	2025-12-11	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	56b923c3-1d4a-47bf-9c9e-c0fdc54c8a2f	2025-10-24	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	96aefbca-fe71-42ef-8079-d0d9e7370ccb	2025-10-22	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	a10bf8b5-bf70-4090-b4b2-a0be252b9fe4	2025-10-22	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Marlex Pharmaceuticals Inc	25af52ee-9b29-4c07-a383-62d4537b63e0	2025-09-10	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	3dd7f2a6-5a91-81a2-e063-6294a90a33db	2025-09-02	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	be411327-5ac7-46df-b5e4-32a11b419b15	2025-08-07	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	8e578f11-6112-4a1f-8de4-a76870bb62c7	2025-07-14	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Advagen Pharma Limited	c3b9e7f0-be6d-4f37-9277-54bb0ba8b158	2025-07-09	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	5232b933-1df9-43b4-8ac2-61bfa4855e68	2025-07-09	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE

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