Application 203548

Type: ANDA
Sponsor: AVANTHI INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	5MG	No	No
002	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE 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
A203548-001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA		2015-11-23
A203548-002	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA		2015-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203548-001	AA
A203548-002	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 3 · 84 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	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203548-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2015-11-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203548-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2015-11-23	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A203548-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203548-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203548-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203548-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203548-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203548-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203548-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203548-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203548-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203548-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203548-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203548-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203548-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203548-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203548-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203548-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203548-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203548-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203548-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203548-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203548-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203548-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203548-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203548-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203548-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203548-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203548-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203548-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203548-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203548-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203548-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203548-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203548-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203548-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203548-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203548-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203548-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203548-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203548-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203548-002	AA	1	`bb7c543d1eb4…`

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
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	KVK-Tech, Inc.	863d66fe-9c38-463a-afa1-552647494c5a	2024-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203548 application number: ANDA203548 ndc (product): 10702-065 ndc (product): 10702-066

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10702-065	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	KVK-Tech, Inc.	ANDA	Current
10702-065	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	KVK-Tech, Inc.	ANDA	Current
10702-065	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	KVK-Tech, Inc.	ANDA	Current
10702-066	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	KVK-Tech, Inc.	ANDA	Current
10702-066	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	KVK-Tech, Inc.	ANDA	Current
10702-066	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	KVK-Tech, Inc.	ANDA	Current