Application 209754

Type: ANDA
Sponsor: BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	10MG	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
A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL			2020-03-24
A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL			2020-03-24

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 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209754-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2020-03-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209754-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-03-24	`87673890dc5c…`

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 2 · 40 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	dd659d39-41f5-4612-8f17-bad602b4784d	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride Extended-Release	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	bb4f32eb-05c7-449e-8e5a-f45781a58f70	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride Extended-Release	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	72d7a084-79cf-44c5-a158-fae1fc2faba4	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	90308fd0-d174-4979-aa22-16290d6cc5bb	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	76aa2130-2b7b-40f7-a35a-d51b21da4636	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride Extended-Release	DEXMETHYLPHENIDATE HYDROCHLORIDE	Par Health USA, LLC	4ed9f3c8-c71f-499e-bb91-c19847bf4444	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	638f614c-bf91-4bf6-876f-bf25fa273bc4	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	KVK-TECH, INC	0c717ae4-ec27-47db-ac1b-e504dbb379be	2025-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DEXMETHYLPHENIDATE HYDROCHLORIDE generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	93e56455-0f15-4ed9-a63a-7fbd0697d520	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	be7019d7-eb3e-48eb-b6ba-0ffefae6dcd0	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride Extended-Release	DEXMETHYLPHENIDATE HYDROCHLORIDE	Lannett Company, Inc.	edad7c67-a872-41ad-a8bd-169278693cc2	2025-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Focalin XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	Sandoz Inc	9cf76f62-48aa-4065-94fd-6fc910391ab5	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Focalin XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	Novartis Pharmaceuticals Corporation	1a1da905-42a0-4748-9c39-67eca45deccc	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	d9c450fa-c8c5-4ff0-a263-4a9eee6f5437	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b64f3622-b3d7-4a1e-9f1f-0ac0fe3dadfe	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b82e8d08-cc4a-40a6-85a5-07717f3cb38b	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b7410d65-9c7f-4ffd-b957-969e2725f38f	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	9700cc3d-52e9-40e4-8595-f1c56279a2e0	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	6593b3ae-efcc-49ff-ba51-3fb5558605e5	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE

Application 209754

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#