Application 083901

Type: ANDA
Sponsor: LANNETT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	TABLET;ORAL	5MG	No	No
002	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	TABLET;ORAL	10MG	No	No

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

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
A083901-001	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-08-31
A083901-002	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-08-31

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A083901-001	AMPHETAMINE SULFATE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A083901-002	AMPHETAMINE SULFATE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A083901-001	AMPHETAMINE SULFATE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083901-002	AMPHETAMINE SULFATE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	RLD	1984-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	RLD	1984-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	RLD	1984-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	RLD	1984-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	RLD	1984-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	RLD	1984-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	RLD	1984-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	RLD	1984-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	RLD	1984-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	RLD	1984-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	RLD	1984-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	RLD	1984-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	RLD	1984-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	RLD	1984-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	RLD	1984-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	RLD	1984-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	RLD	1984-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	RLD	1984-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	RLD	1984-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	RLD	1984-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	RLD	1984-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	RLD	1984-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	RLD	1984-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	RLD	1984-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	RLD	1984-08-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	RLD	1984-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	RLD	1984-08-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	RLD	1984-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	RLD	1984-08-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	RLD	1984-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	RLD	1984-08-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	RLD	1984-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	RLD	1984-08-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	RLD	1984-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL		1984-08-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL		1984-08-31	`74a2ff9319b5…`

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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Bryant Ranch Prepack	8f9341fc-4b95-4556-a51a-ea972fa6fccc	2024-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: AMPHETAMINE SULFATE generic name: AMPHETAMINE SULFATE
Amphetamine sulfate	AMPHETAMINE SULFATE TABLETS	DR. REDDY'S LABORATORIES INC	79b9db39-7cdc-5607-f0ce-ac2a2cfd59d5	2023-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amphetamine sulfate
Amphetamine Sulfate	AMPHETAMINE SULFATE	SpecGx LLC	00242264-40d8-4267-a91a-727a1f088616	2023-05-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amphetamine Sulfate generic name: AMPHETAMINE SULFATE

Reported adverse events (FAERS/openFDA)#

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