Application 211546

Type: ANDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	3.125MG;3.125MG;3.125MG;3.125MG	No	No
002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	6.25MG;6.25MG;6.25MG;6.25MG	No	No
003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	9.375MG;9.375MG;9.375MG;9.375MG	No	No
004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	12.5MG;12.5MG;12.5MG;12.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	TE codes	Approval date
A211546-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31
A211546-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31
A211546-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31
A211546-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A211546-001	AB2
A211546-002	AB2
A211546-003	AB2
A211546-004	AB2

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 2 of 3 · 92 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
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211546-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211546-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211546-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211546-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211546-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211546-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211546-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211546-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211546-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211546-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211546-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211546-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211546-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211546-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211546-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211546-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211546-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211546-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211546-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211546-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211546-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211546-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211546-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211546-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211546-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211546-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211546-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211546-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211546-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211546-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211546-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211546-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211546-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211546-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211546-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211546-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211546-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-08-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211546-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-08-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211546-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-08-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211546-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-08-31	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A211546-001	AB2	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211546-002	AB2	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211546-003	AB2	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211546-004	AB2	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211546-001	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211546-002	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211546-003	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211546-004	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211546-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211546-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211546-003	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211546-004	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211546-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211546-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211546-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211546-004	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211546-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211546-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211546-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211546-004	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211546-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211546-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211546-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211546-004	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211546-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211546-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211546-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211546-004	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211546-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211546-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211546-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211546-004	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211546-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211546-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211546-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211546-004	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211546-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211546-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211546-003	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211546-004	AB2	1	`2680178bc6a6…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mixed Salts of a Single-Entity Amphetamine Product	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE	SpecGx LLC	e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211546 application number: ANDA211546

Reported adverse events (FAERS/openFDA)#

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