Application 212901

Type: ANDA
Sponsor: HAVIX

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 1.

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
A212901-001	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA		2020-05-22
A212901-002	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA		2020-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212901-001	AA
A212901-002	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 · 74 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	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212901-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-05-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212901-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-05-22	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A212901-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212901-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212901-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212901-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212901-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212901-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212901-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212901-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212901-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212901-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212901-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212901-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212901-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212901-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212901-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212901-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212901-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212901-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212901-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212901-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212901-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212901-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212901-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212901-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212901-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212901-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212901-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212901-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212901-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212901-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212901-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212901-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212901-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212901-002	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212901-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212901-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212901-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212901-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212901-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212901-002	AA	1	`87673890dc5c…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amphetamine Sulfate	AMPHETAMINE SULFATE	Amici Pharma, Inc.	e045dc28-e05d-4407-9d44-d0a11ca558e6	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212901 application number: ANDA212901
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Bryant Ranch Prepack	9817a519-fdb0-474a-92f4-2e485c9cb047	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212901 application number: ANDA212901
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Bryant Ranch Prepack	9eb84b3c-2147-42dd-8053-6afd1a88b0c1	2025-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212901 application number: ANDA212901 ndc (product): 63629-2078
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Bryant Ranch Prepack	3ad894e3-78a7-4e3b-80d1-1a925fb6d9e3	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212901 application number: ANDA212901
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Bryant Ranch Prepack	698171ee-4328-476a-b71c-58aa6dc93b23	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212901 application number: ANDA212901
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Bryant Ranch Prepack	c00bbade-3dc8-422b-8cff-f85db408bdfc	2024-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212901 application number: ANDA212901 ndc (product): 63629-2079
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Lannett Company, Inc.	85a015a7-a1a0-4b04-8bc4-7aacd0c84742	2024-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212901 application number: ANDA212901 ndc (product): 0527-2524 ndc (product): 0527-2525

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-2524	AMPHETAMINE SULFATE	amphetamine sulfate	Lannett Company, Inc.	ANDA	Current
0527-2524	AMPHETAMINE SULFATE	amphetamine sulfate	Lannett Company, Inc.	ANDA	Current
0527-2524	AMPHETAMINE SULFATE	amphetamine sulfate	Lannett Company, Inc.	ANDA	Current
0527-2524	AMPHETAMINE SULFATE	amphetamine sulfate	Lannett Company, Inc.	ANDA	Current
0527-2525	AMPHETAMINE SULFATE	amphetamine sulfate	Lannett Company, Inc.	ANDA	Current
0527-2525	AMPHETAMINE SULFATE	amphetamine sulfate	Lannett Company, Inc.	ANDA	Current
0527-2525	AMPHETAMINE SULFATE	amphetamine sulfate	Lannett Company, Inc.	ANDA	Current
0527-2525	AMPHETAMINE SULFATE	amphetamine sulfate	Lannett Company, Inc.	ANDA	Current
63629-2078	AMPHETAMINE SULFATE	amphetamine sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2078	AMPHETAMINE SULFATE	amphetamine sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2078	AMPHETAMINE SULFATE	amphetamine sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2079	AMPHETAMINE SULFATE	amphetamine sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2079	AMPHETAMINE SULFATE	amphetamine sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2079	AMPHETAMINE SULFATE	amphetamine sulfate	Bryant Ranch Prepack	ANDA	Current
71337-024	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Havix Group Inc d-b-a Aavis Pharmaceuticals	ANDA	Current
71337-024	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Havix Group Inc d-b-a Aavis Pharmaceuticals	ANDA	Current
71337-025	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Havix Group Inc d-b-a Aavis Pharmaceuticals	ANDA	Current
71337-025	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Havix Group Inc d-b-a Aavis Pharmaceuticals	ANDA	Current