Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

Product NDC
69452-203
11-digit product format
694520203
Labeler code
69452
Product ID
69452-203_a2c8206a-a8be-5a96-e053-2a95a90a0d4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Bionpharma Inc
Application
ANDA210293
Marketing category
ANDA
Marketing start
2020-10-15
Marketing end
0000-00-00
Substance
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE
Active strength
5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69452-203DDiscontinued by firm2026-08-10
excluded packagepackage69452-20369452-203-20DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69452-203-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69452-203-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69452-203-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69452-203-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69452-203-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69452-203-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69452-203-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69452-203-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69452-203-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69452-203-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69452-203-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69452-203-20557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210293-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2020-04-03
A210293-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2020-04-03
A210293-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2020-04-03
A210293-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2020-04-03
A210293-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2020-04-03
A210293-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2020-04-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A210293-001AB
A210293-002AB
A210293-003AB
A210293-004AB
A210293-005AB
A210293-006AB

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 · 222 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210293-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2020-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210293-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2020-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210293-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2020-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210293-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2020-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210293-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2020-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210293-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2020-04-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210293-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2020-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210293-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2020-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210293-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2020-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210293-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2020-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210293-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2020-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210293-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2020-04-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210293-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2020-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210293-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2020-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210293-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2020-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210293-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2020-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210293-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2020-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210293-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2020-04-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210293-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2020-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210293-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2020-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210293-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2020-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210293-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2020-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210293-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2020-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210293-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2020-04-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210293-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2020-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210293-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2020-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210293-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2020-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210293-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2020-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210293-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2020-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210293-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2020-04-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210293-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2020-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210293-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2020-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210293-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2020-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210293-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2020-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210293-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2020-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210293-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2020-04-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210293-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2020-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210293-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2020-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210293-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2020-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210293-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2020-04-032680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 222 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210293-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210293-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210293-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210293-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210293-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210293-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210293-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210293-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210293-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210293-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210293-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210293-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210293-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210293-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210293-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210293-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210293-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210293-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210293-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210293-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210293-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210293-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210293-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210293-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210293-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210293-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210293-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210293-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210293-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210293-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210293-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210293-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210293-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210293-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210293-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210293-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210293-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210293-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210293-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210293-004AB12680178bc6a6…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEOryza Pharmaceuticals Inc.acd27181-a3f3-4c38-85d8-029a4a82e7c22025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210293
application number: ANDA210293