Application 215997

Type: ANDA
Sponsor: SUN PHARM INDS INC

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
A215997-001	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	2023-09-27
A215997-002	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	2023-09-27
A215997-003	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	2023-09-27
A215997-004	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	2023-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215997-001	AB2
A215997-002	AB2
A215997-003	AB2
A215997-004	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 1 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
2026-10-15 13:18:30	2026-09	A215997-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A215997-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A215997-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A215997-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A215997-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215997-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215997-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215997-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215997-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215997-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215997-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215997-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215997-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215997-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215997-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215997-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215997-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215997-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215997-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215997-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215997-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215997-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215997-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215997-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215997-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215997-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215997-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215997-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215997-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215997-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215997-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215997-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215997-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215997-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215997-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215997-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215997-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215997-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215997-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215997-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2023-09-27	`2680178bc6a6…`

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	A215997-001	AB2	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A215997-002	AB2	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A215997-003	AB2	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A215997-004	AB2	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A215997-001	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215997-002	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215997-003	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215997-004	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215997-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215997-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215997-003	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215997-004	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215997-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215997-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215997-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215997-004	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215997-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215997-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215997-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215997-004	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215997-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215997-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215997-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215997-004	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215997-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215997-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215997-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215997-004	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215997-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215997-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215997-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215997-004	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215997-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215997-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215997-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215997-004	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215997-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215997-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215997-003	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215997-004	AB2	1	`2680178bc6a6…`

Reported adverse events (FAERS/openFDA)#

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