Application 212160

Type: ANDA
Sponsor: WINDER LABS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	2.5MG	No	No
002	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	5MG	No	No
003	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	7.5MG	No	No
004	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	10MG	No	No
005	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	15MG	No	No
006	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	20MG	No	No
007	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	30MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A212160-001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2021-06-07
A212160-002	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-06-07
A212160-003	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2021-06-07
A212160-004	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-06-07
A212160-005	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2021-06-07
A212160-006	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2021-06-07
A212160-007	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2021-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212160-001	AA
A212160-002	AA
A212160-003	AA
A212160-004	AA
A212160-005	AA
A212160-006	AA
A212160-007	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 6 · 238 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	A212160-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2021-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212160-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212160-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2021-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212160-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212160-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2021-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212160-006	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2021-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212160-007	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2021-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212160-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2021-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2021-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2021-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-006	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2021-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-007	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2021-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2021-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2021-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2021-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-006	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2021-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-007	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2021-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212160-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2021-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2021-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2021-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-006	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2021-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-007	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2021-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2021-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2021-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2021-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-006	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2021-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-007	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2021-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2021-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2021-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2021-06-07	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 175 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	A212160-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212160-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212160-003	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212160-004	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212160-005	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212160-006	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212160-007	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212160-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-004	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-005	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-006	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-007	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-004	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-005	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-006	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-007	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212160-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-004	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-005	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-006	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-007	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-004	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-005	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-006	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-007	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-004	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-005	AA	1	`b8a1b40f171c…`

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	Winder Laboratories LLC	ca1a8890-0675-4c9c-9716-6c28f975d827	2025-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212160 application number: ANDA212160 ndc (product): 75826-121 ndc (product): 75826-122 ndc (product): 75826-123 ndc (product): 75826-120 ndc (product): 75826-126 ndc (product): 75826-124 ndc (product): 75826-125

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
75826-120	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-120	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-120	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-120	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-121	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-121	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-121	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-121	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-122	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-122	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-122	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-122	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-123	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-123	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-123	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-123	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-124	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-124	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-124	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-124	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-125	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-125	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-125	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-125	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-126	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-126	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-126	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-126	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current