Application 090533

Type
ANDA
Sponsor
ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL2.5MGNoNo
002DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL5MGNoNo
003DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL7.5MGNoNo
004DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL10MGNoNo
005DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL15MGNoNo
006DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL20MGNoNo
007DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL30MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090533-001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE2.5MGTABLET / ORALAA2011-10-25
A090533-002DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE5MGTABLET / ORALAA2011-10-25
A090533-003DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE7.5MGTABLET / ORALAA2011-10-25
A090533-004DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE10MGTABLET / ORALAA2011-10-25
A090533-005DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE15MGTABLET / ORALAA2011-10-25
A090533-006DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE20MGTABLET / ORALAA2011-10-25
A090533-007DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE30MGTABLET / ORALAA2011-10-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090533-001AA
A090533-002AA
A090533-003AA
A090533-004AA
A090533-005AA
A090533-006AA
A090533-007AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090533-001DEXTROAMPHETAMINE SULFATE2.5MGTABLET / ORALAA2011-10-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090533-002DEXTROAMPHETAMINE SULFATE5MGTABLET / ORALAA2011-10-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090533-003DEXTROAMPHETAMINE SULFATE7.5MGTABLET / ORALAA2011-10-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090533-004DEXTROAMPHETAMINE SULFATE10MGTABLET / ORALAA2011-10-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090533-005DEXTROAMPHETAMINE SULFATE15MGTABLET / ORALAA2011-10-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090533-006DEXTROAMPHETAMINE SULFATE20MGTABLET / ORALAA2011-10-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090533-007DEXTROAMPHETAMINE SULFATE30MGTABLET / ORALAA2011-10-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090533-001DEXTROAMPHETAMINE SULFATE2.5MGTABLET / ORALAA2011-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090533-002DEXTROAMPHETAMINE SULFATE5MGTABLET / ORALAA2011-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090533-003DEXTROAMPHETAMINE SULFATE7.5MGTABLET / ORALAA2011-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090533-004DEXTROAMPHETAMINE SULFATE10MGTABLET / ORALAA2011-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090533-005DEXTROAMPHETAMINE SULFATE15MGTABLET / ORALAA2011-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090533-006DEXTROAMPHETAMINE SULFATE20MGTABLET / ORALAA2011-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090533-007DEXTROAMPHETAMINE SULFATE30MGTABLET / ORALAA2011-10-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090533-001DEXTROAMPHETAMINE SULFATE2.5MGTABLET / ORALAA2011-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090533-002DEXTROAMPHETAMINE SULFATE5MGTABLET / ORALAA2011-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090533-003DEXTROAMPHETAMINE SULFATE7.5MGTABLET / ORALAA2011-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090533-004DEXTROAMPHETAMINE SULFATE10MGTABLET / ORALAA2011-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090533-005DEXTROAMPHETAMINE SULFATE15MGTABLET / ORALAA2011-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090533-006DEXTROAMPHETAMINE SULFATE20MGTABLET / ORALAA2011-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090533-007DEXTROAMPHETAMINE SULFATE30MGTABLET / ORALAA2011-10-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090533-001DEXTROAMPHETAMINE SULFATE2.5MGTABLET / ORALAA2011-10-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090533-002DEXTROAMPHETAMINE SULFATE5MGTABLET / ORALAA2011-10-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090533-003DEXTROAMPHETAMINE SULFATE7.5MGTABLET / ORALAA2011-10-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090533-004DEXTROAMPHETAMINE SULFATE10MGTABLET / ORALAA2011-10-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090533-005DEXTROAMPHETAMINE SULFATE15MGTABLET / ORALAA2011-10-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090533-006DEXTROAMPHETAMINE SULFATE20MGTABLET / ORALAA2011-10-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090533-007DEXTROAMPHETAMINE SULFATE30MGTABLET / ORALAA2011-10-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090533-001DEXTROAMPHETAMINE SULFATE2.5MGTABLET / ORALAA2011-10-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090533-002DEXTROAMPHETAMINE SULFATE5MGTABLET / ORALAA2011-10-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090533-003DEXTROAMPHETAMINE SULFATE7.5MGTABLET / ORALAA2011-10-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090533-004DEXTROAMPHETAMINE SULFATE10MGTABLET / ORALAA2011-10-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090533-005DEXTROAMPHETAMINE SULFATE15MGTABLET / ORALAA2011-10-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090533-006DEXTROAMPHETAMINE SULFATE20MGTABLET / ORALAA2011-10-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090533-007DEXTROAMPHETAMINE SULFATE30MGTABLET / ORALAA2011-10-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090533-001DEXTROAMPHETAMINE SULFATE2.5MGTABLET / ORALAA2011-10-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090533-002DEXTROAMPHETAMINE SULFATE5MGTABLET / ORALAA2011-10-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090533-003DEXTROAMPHETAMINE SULFATE7.5MGTABLET / ORALAA2011-10-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090533-004DEXTROAMPHETAMINE SULFATE10MGTABLET / ORALAA2011-10-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090533-005DEXTROAMPHETAMINE SULFATE15MGTABLET / ORALAA2011-10-2503ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 202 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090533-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090533-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090533-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090533-004AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090533-005AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090533-006AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090533-007AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090533-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090533-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090533-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090533-004AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090533-005AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090533-006AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090533-007AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090533-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090533-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090533-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090533-004AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090533-005AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090533-006AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090533-007AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090533-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090533-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090533-003AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090533-004AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090533-005AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090533-006AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090533-007AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090533-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090533-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090533-003AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090533-004AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090533-005AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090533-006AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090533-007AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090533-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090533-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090533-003AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090533-004AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090533-005AA103ed91905a0d…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZenzediDEXTROAMPHETAMINE SULFATEAzurity Pharmaceuticals, Inc.d6394df5-f2c9-47eb-b57e-f3e9cfd94f842025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090533
application number: ANDA090533
ndc (product): 24338-855
ndc (product): 24338-853
ndc (product): 24338-856
ndc (product): 24338-850
ndc (product): 24338-852
ndc (product): 24338-854
ndc (product): 24338-851
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEBryant Ranch Prepack9346ff55-b751-4919-ae63-eb58b69e3f0f2025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090533
application number: ANDA090533
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEBryant Ranch Prepack54b122b0-2ec8-43c9-86e8-a3538a83c7762025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090533
application number: ANDA090533
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEBryant Ranch Prepack9f1c9cb0-7752-40cc-8ed1-5e79b8dc9da22025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090533
application number: ANDA090533
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEBryant Ranch Prepackfc164327-dd48-4851-b613-71d957ee60662025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090533
application number: ANDA090533
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEBryant Ranch Prepackb40c9a90-7e2e-48d6-adb6-2351c0ca621d2025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090533
application number: ANDA090533
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEWilshire Pharmaceuticals, Inc.6b8c97ac-c83c-4a1f-a33c-121239253abf2025-06-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090533
application number: ANDA090533
ndc (product): 52536-515
ndc (product): 52536-510
ndc (product): 52536-530
ndc (product): 52536-500
ndc (product): 52536-520

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24338-850ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-850ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-850ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-850ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-851ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-851ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-851ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-851ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-852ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-852ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-852ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-852ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-853ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-853ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-853ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-853ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-854ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-854ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-854ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-854ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-855ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-855ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-855ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-855ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-856ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-856ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-856ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-856ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
52536-500Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-500Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-500Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-500Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-510Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-510Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-510Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-510Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-515Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-515Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-520Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-520Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-530Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-530Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85123SUPPL 2026-02-24
85122SUPPL 2026-02-24