Application 217194

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	CAPSULE;ORAL	10MG	No	No
002	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	CAPSULE;ORAL	20MG	No	No
003	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	CAPSULE;ORAL	30MG	No	No
004	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	CAPSULE;ORAL	40MG	No	No
005	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	CAPSULE;ORAL	50MG	No	No
006	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	CAPSULE;ORAL	60MG	No	No
007	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	CAPSULE;ORAL	70MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A217194-001	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2023-08-25
A217194-002	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25
A217194-003	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25
A217194-004	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25
A217194-005	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25
A217194-006	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25
A217194-007	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A217194-001	AB
A217194-002	AB
A217194-003	AB
A217194-004	AB
A217194-005	AB
A217194-006	AB
A217194-007	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 4 · 140 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
2026-02-19 14:30 UTC	2026-02	A217194-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217194-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217194-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217194-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217194-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217194-006	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217194-007	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217194-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217194-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217194-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217194-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217194-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217194-006	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217194-007	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217194-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217194-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217194-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217194-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217194-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217194-006	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217194-007	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217194-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217194-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217194-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217194-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217194-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217194-006	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217194-007	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217194-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217194-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217194-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217194-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217194-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217194-006	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217194-007	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217194-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217194-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217194-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217194-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217194-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217194-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217194-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217194-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217194-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217194-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217194-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217194-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217194-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217194-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217194-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217194-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217194-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217194-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217194-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217194-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217194-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217194-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217194-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217194-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217194-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217194-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217194-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217194-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217194-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217194-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217194-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217194-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217194-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217194-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217194-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217194-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217194-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217194-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217194-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217194-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217194-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217194-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217194-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217194-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217194-005	AB	1	`03ed91905a0d…`

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 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisdexamfetamine dimesylate	LISDEXAMFETAMINE DIMESYLATE	Granules Pharmaceuticals Inc.	c56b4712-2fb8-4c7a-bfbd-0401d9f5f92a	2026-07-13	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	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisdexamfetamine dimesylate generic 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.	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	Lannett Company, Inc.	2cedb4c2-1e40-4bc4-b9f4-127150c4afbd	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisdexamfetamine Dimesylate generic name: LISDEXAMFETAMINE DIMESYLATE
Lisdexamfetamine Dimesylate	LISDEXAMFETAMINE	Amneal Pharmaceuticals LLC	c11cb3b6-3dff-477b-a249-b4c3118edc5f	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand 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	Apotex Corp.	ecad4442-a644-18e3-6ff2-fdbac45eec47	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisdexamfetamine Dimesylate 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