Application 040480

Type: ANDA
Sponsor: SUN PHARM INDUSTRIES

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	TABLET;ORAL	1.25MG;1.25MG;1.25MG;1.25MG	No	No
002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	1.875MG;1.875MG;1.875MG;1.875MG	No	No
003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	2.5MG;2.5MG;2.5MG;2.5MG	No	No
004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	3.125MG;3.125MG;3.125MG;3.125MG	No	No
005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	3.75MG;3.75MG;3.75MG;3.75MG	No	No
006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	5MG;5MG;5MG;5MG	No	No
007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	7.5MG;7.5MG;7.5MG;7.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040480-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	AB	2003-09-09
A040480-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	AB	2003-09-09
A040480-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	AB	2003-09-09
A040480-004	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	TABLET / ORAL	AB	2003-09-09
A040480-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	AB	2003-09-09
A040480-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	AB	2003-09-09
A040480-007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	TABLET / ORAL	AB	2003-09-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A040480-001	AB
A040480-002	AB
A040480-003	AB
A040480-004	AB
A040480-005	AB
A040480-006	AB
A040480-007	AB

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 8 · 287 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	A040480-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	AB	2003-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040480-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	AB	2003-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040480-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	AB	2003-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040480-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	AB	2003-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040480-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	AB	2003-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040480-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	AB	2003-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040480-007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	TABLET / ORAL	AB	2003-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040480-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	AB	2003-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040480-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	AB	2003-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040480-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	AB	2003-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040480-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	AB	2003-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040480-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	AB	2003-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040480-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	AB	2003-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040480-007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	TABLET / ORAL	AB	2003-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040480-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	AB	2003-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040480-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	AB	2003-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040480-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	AB	2003-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040480-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	AB	2003-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040480-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	AB	2003-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040480-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	AB	2003-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040480-007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	TABLET / ORAL	AB	2003-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040480-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	AB	2003-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040480-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	AB	2003-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040480-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	AB	2003-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040480-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	AB	2003-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040480-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	AB	2003-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040480-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	AB	2003-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040480-007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	TABLET / ORAL	AB	2003-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040480-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	AB	2003-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040480-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	AB	2003-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040480-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	AB	2003-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040480-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	AB	2003-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040480-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	AB	2003-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040480-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	AB	2003-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040480-007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	TABLET / ORAL	AB	2003-09-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040480-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	AB	2003-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040480-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	AB	2003-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040480-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	AB	2003-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040480-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	AB	2003-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040480-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	AB	2003-09-09	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 287 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	A040480-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040480-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040480-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040480-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040480-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040480-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040480-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040480-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040480-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040480-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040480-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040480-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040480-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040480-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040480-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040480-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040480-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040480-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040480-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040480-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040480-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040480-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040480-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040480-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040480-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040480-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040480-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040480-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040480-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040480-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040480-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040480-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040480-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040480-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040480-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040480-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040480-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040480-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040480-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040480-005	AB	1	`03ed91905a0d…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE	Sun Pharmaceutical Industries, Inc.	9af67219-9b37-45d0-ac52-647cbfacd296	2024-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040480 application number: ANDA040480 ndc (product): 57664-642 ndc (product): 57664-644 ndc (product): 57664-647 ndc (product): 57664-641 ndc (product): 57664-645 ndc (product): 57664-646 ndc (product): 57664-643
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE	Bryant Ranch Prepack	b90efc87-f328-4501-b7bb-d059ac501f7f	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040480 application number: ANDA040480 ndc (product): 71335-0171
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE	Northstar Rx LLC	facdf159-1d95-4981-a8ad-d82edcc14a0c	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040480 application number: ANDA040480 ndc (product): 16714-805 ndc (product): 16714-807 ndc (product): 16714-803 ndc (product): 16714-806 ndc (product): 16714-808 ndc (product): 16714-802 ndc (product): 16714-804

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-802	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Northstar Rx LLC	ANDA	Current
16714-802	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Northstar Rx LLC	ANDA	Current
16714-803	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Northstar Rx LLC	ANDA	Current
16714-803	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Northstar Rx LLC	ANDA	Current
16714-804	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Northstar Rx LLC	ANDA	Current
16714-804	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Northstar Rx LLC	ANDA	Current
16714-805	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Northstar Rx LLC	ANDA	Current
16714-805	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Northstar Rx LLC	ANDA	Current
16714-806	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Northstar Rx LLC	ANDA	Current
16714-806	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Northstar Rx LLC	ANDA	Current
16714-807	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Northstar Rx LLC	ANDA	Current
16714-807	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Northstar Rx LLC	ANDA	Current
16714-808	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Northstar Rx LLC	ANDA	Current
16714-808	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Northstar Rx LLC	ANDA	Current
57664-641	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-641	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-641	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-641	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-642	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-642	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-642	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-642	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-643	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-643	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-643	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-643	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-644	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-644	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-644	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-644	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-645	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-645	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-645	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-645	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-646	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-646	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-646	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-646	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-647	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-647	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-647	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-647	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
71335-0171	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Bryant Ranch Prepack	ANDA	Current
71335-0171	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Bryant Ranch Prepack	ANDA	Current
71335-0171	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Bryant Ranch Prepack	ANDA	Current
71335-0198	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Bryant Ranch Prepack	ANDA	Current
71335-0198	Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate	Bryant Ranch Prepack	ANDA	Current