Application 218850

Type: ANDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	TABLET, CHEWABLE;ORAL	10MG	No	No
002	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	TABLET, CHEWABLE;ORAL	20MG	No	No
003	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	TABLET, CHEWABLE;ORAL	30MG	No	No
004	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	TABLET, CHEWABLE;ORAL	40MG	No	No
005	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	TABLET, CHEWABLE;ORAL	50MG	No	No
006	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	TABLET, CHEWABLE;ORAL	60MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A218850-001	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	10MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17
A218850-002	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	20MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17
A218850-003	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	30MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17
A218850-004	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	40MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17
A218850-005	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	50MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17
A218850-006	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	60MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A218850-001	AB
A218850-002	AB
A218850-003	AB
A218850-004	AB
A218850-005	AB
A218850-006	AB

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 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A218850-001	LISDEXAMFETAMINE DIMESYLATE	10MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218850-002	LISDEXAMFETAMINE DIMESYLATE	20MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218850-003	LISDEXAMFETAMINE DIMESYLATE	30MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218850-004	LISDEXAMFETAMINE DIMESYLATE	40MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218850-005	LISDEXAMFETAMINE DIMESYLATE	50MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218850-006	LISDEXAMFETAMINE DIMESYLATE	60MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218850-001	LISDEXAMFETAMINE DIMESYLATE	10MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218850-002	LISDEXAMFETAMINE DIMESYLATE	20MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218850-003	LISDEXAMFETAMINE DIMESYLATE	30MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218850-004	LISDEXAMFETAMINE DIMESYLATE	40MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218850-005	LISDEXAMFETAMINE DIMESYLATE	50MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218850-006	LISDEXAMFETAMINE DIMESYLATE	60MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218850-001	LISDEXAMFETAMINE DIMESYLATE	10MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218850-002	LISDEXAMFETAMINE DIMESYLATE	20MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218850-003	LISDEXAMFETAMINE DIMESYLATE	30MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218850-004	LISDEXAMFETAMINE DIMESYLATE	40MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218850-005	LISDEXAMFETAMINE DIMESYLATE	50MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218850-006	LISDEXAMFETAMINE DIMESYLATE	60MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218850-001	LISDEXAMFETAMINE DIMESYLATE	10MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218850-002	LISDEXAMFETAMINE DIMESYLATE	20MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218850-003	LISDEXAMFETAMINE DIMESYLATE	30MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218850-004	LISDEXAMFETAMINE DIMESYLATE	40MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218850-005	LISDEXAMFETAMINE DIMESYLATE	50MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218850-006	LISDEXAMFETAMINE DIMESYLATE	60MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218850-001	LISDEXAMFETAMINE DIMESYLATE	10MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218850-002	LISDEXAMFETAMINE DIMESYLATE	20MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218850-003	LISDEXAMFETAMINE DIMESYLATE	30MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218850-004	LISDEXAMFETAMINE DIMESYLATE	40MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218850-005	LISDEXAMFETAMINE DIMESYLATE	50MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218850-006	LISDEXAMFETAMINE DIMESYLATE	60MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218850-001	LISDEXAMFETAMINE DIMESYLATE	10MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218850-002	LISDEXAMFETAMINE DIMESYLATE	20MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218850-003	LISDEXAMFETAMINE DIMESYLATE	30MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218850-004	LISDEXAMFETAMINE DIMESYLATE	40MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218850-005	LISDEXAMFETAMINE DIMESYLATE	50MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218850-006	LISDEXAMFETAMINE DIMESYLATE	60MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218850-001	LISDEXAMFETAMINE DIMESYLATE	10MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218850-002	LISDEXAMFETAMINE DIMESYLATE	20MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218850-003	LISDEXAMFETAMINE DIMESYLATE	30MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218850-004	LISDEXAMFETAMINE DIMESYLATE	40MG	TABLET, CHEWABLE / ORAL	AB	2024-12-17	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218850-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218850-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218850-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218850-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218850-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218850-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218850-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218850-006	AB	1	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218850-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218850-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218850-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218850-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218850-005	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218850-006	AB	1	`a50c72e98297…`

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 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisdexamfetamine Dimesylate	LISDEXAMFETAMINE	Amneal Pharmaceuticals LLC	c11cb3b6-3dff-477b-a249-b4c3118edc5f	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisdexamfetamine Dimesylate
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Sun Pharmaceutical Industries, Inc.	da3148af-f9b6-4725-adae-3595b4c7dc4b	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISDEXAMFETAMINE DIMESYLATE generic name: LISDEXAMFETAMINE DIMESYLATE
Lisdexamfetamine dimesylate	LISDEXAMFETAMINE DIMESYLATE	Teva Pharmaceuticals, Inc.	c32b5dce-2de4-4db0-a4ba-d2ce3b0a32fc	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisdexamfetamine dimesylate generic name: LISDEXAMFETAMINE DIMESYLATE
lisdexamfetamine dimesylate	LISDEXAMFETAMINE DIMESYLATE	Teva Pharmaceuticals, Inc.	bdb03bfa-0398-41e5-8e73-ded696cbca32	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lisdexamfetamine dimesylate generic name: LISDEXAMFETAMINE DIMESYLATE
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Bryant Ranch Prepack	281842ea-d165-4b6d-a366-791239be8c2e	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISDEXAMFETAMINE DIMESYLATE generic name: LISDEXAMFETAMINE DIMESYLATE
Lisdexamfetamine Dimesylate	LISDEXAMFETAMINE DIMESYLATE	Elite Laboratories, Inc.	0e024b69-567c-4b40-9c3e-a2daec34256c	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisdexamfetamine Dimesylate generic name: LISDEXAMFETAMINE DIMESYLATE
Lisdexamfetamine Dimesylate	LISDEXAMFETAMINE	Mylan Pharmaceuticals Inc.	efbde0f6-b848-4664-b741-c6c630e66108	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisdexamfetamine Dimesylate
Lisdexamfetamine dimesylate	LISDEXAMFETAMINE DIMESYLATE CAPSULES	Solco Healthcare US,LLC	68b10d9f-ca3e-493d-a309-45f1d7e08061	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisdexamfetamine dimesylate
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Camber Pharmaceuticals, Inc.	f05bac63-08a5-49ce-8180-b33b76c0c0c4	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISDEXAMFETAMINE DIMESYLATE generic name: LISDEXAMFETAMINE DIMESYLATE
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Granules Pharmaceuticals Inc.	c91c6acf-b68c-4832-a06f-d0fbd6b80457	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISDEXAMFETAMINE DIMESYLATE generic name: LISDEXAMFETAMINE DIMESYLATE
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Rhodes Pharmaceuticals LLC	d918b40d-a461-41bc-b6c0-83dc76c28e32	2026-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISDEXAMFETAMINE DIMESYLATE generic name: LISDEXAMFETAMINE DIMESYLATE
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Camber Pharmaceuticals, Inc.	20baa61e-be0b-41a3-a896-29e8ce8c4799	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISDEXAMFETAMINE DIMESYLATE generic name: LISDEXAMFETAMINE DIMESYLATE
lisdexamfetamine dimesylate	LISDEXAMFETAMINE DIMESYLATE	Alvogen Inc.	7f2dd6ee-3363-c87c-9693-ed838942556c	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lisdexamfetamine dimesylate generic name: LISDEXAMFETAMINE DIMESYLATE
Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	704e4378-ca83-445c-8b45-3cfa51c1ecad	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISDEXAMFETAMINE DIMESYLATE
Lisdexamfetamine dimesylate	LISDEXAMFETAMINE DIMESYLATE	Sandoz Inc	808cce3b-eee8-4f58-8d8a-53a4ce79ae7c	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisdexamfetamine dimesylate generic name: LISDEXAMFETAMINE DIMESYLATE
Lisdexamfetamine Dimesylate	LISDEXAMFETAMINE DIMESYLATE	Hikma Pharmaceuticals USA Inc.	6740a621-9bec-4178-a4fc-a3fc89f34e0a	2026-04-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisdexamfetamine Dimesylate generic name: LISDEXAMFETAMINE DIMESYLATE
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Bryant Ranch Prepack	483cc379-fd34-45aa-a5c0-09c4d0c167d9	2026-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISDEXAMFETAMINE DIMESYLATE generic name: LISDEXAMFETAMINE DIMESYLATE
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Bryant Ranch Prepack	768d3b93-c1c6-4bf2-a4d8-cee017ab4a16	2026-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISDEXAMFETAMINE DIMESYLATE generic name: LISDEXAMFETAMINE DIMESYLATE
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Bryant Ranch Prepack	b548020c-dd53-4929-96d6-175a78eba5bb	2026-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISDEXAMFETAMINE DIMESYLATE generic name: LISDEXAMFETAMINE DIMESYLATE
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Bryant Ranch Prepack	3b69003f-f7b4-4e52-acde-4b229d6c51fe	2026-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISDEXAMFETAMINE DIMESYLATE generic name: LISDEXAMFETAMINE DIMESYLATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.