Application 211861

Type: ANDA
Sponsor: PRINSTON INC

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 42.

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
A211861-001	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA		2020-03-11
A211861-002	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA		2020-03-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A211861-001	AA
A211861-002	AA

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 · 76 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
2026-08-18 06:07:40	2026-07	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211861-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211861-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211861-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211861-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211861-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211861-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211861-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211861-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211861-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211861-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211861-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211861-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211861-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211861-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211861-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211861-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211861-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211861-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211861-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211861-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211861-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211861-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211861-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211861-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211861-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211861-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211861-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211861-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211861-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211861-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211861-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211861-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211861-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211861-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211861-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211861-002	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211861-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211861-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211861-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211861-002	AA	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Solco Healthcare US, LLC	89c5b52f-3c2a-41d5-8624-9ee51c512c72	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211861 application number: ANDA211861 ndc (product): 43547-458 ndc (product): 43547-457
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Bryant Ranch Prepack	ad4ce013-331b-4359-898f-bac97d64874f	2024-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211861 application number: ANDA211861
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Bryant Ranch Prepack	7f16dd18-bf30-41ef-8981-932da5df0951	2024-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211861 application number: ANDA211861
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Bryant Ranch Prepack	8f9341fc-4b95-4556-a51a-ea972fa6fccc	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211861 application number: ANDA211861 ndc (product): 63629-1115 ndc (product): 63629-1114

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-457	AMPHETAMINE SULFATE	amphetamine sulfate	Solco Healthcare US, LLC	ANDA	Current
43547-457	AMPHETAMINE SULFATE	amphetamine sulfate	Solco Healthcare US, LLC	ANDA	Current
43547-458	AMPHETAMINE SULFATE	amphetamine sulfate	Solco Healthcare US, LLC	ANDA	Current
43547-458	AMPHETAMINE SULFATE	amphetamine sulfate	Solco Healthcare US, LLC	ANDA	Current
63629-1114	AMPHETAMINE SULFATE	amphetamine sulfate	Bryant Ranch Prepack	ANDA	Current
63629-1114	AMPHETAMINE SULFATE	amphetamine sulfate	Bryant Ranch Prepack	ANDA	Current
63629-1115	AMPHETAMINE SULFATE	amphetamine sulfate	Bryant Ranch Prepack	ANDA	Current
63629-1115	AMPHETAMINE SULFATE	amphetamine sulfate	Bryant Ranch Prepack	ANDA	Current