FDA.reportPublic FDA data

Application 090652

Type
ANDA
Sponsor
EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL5MGNoNo
002DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL10MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090652-001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE5MGTABLET / ORAL2014-03-07
A090652-002DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE10MGTABLET / ORAL2014-03-07

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090652-001DEXTROAMPHETAMINE SULFATE5MGTABLET / ORAL2014-03-07a50c72e98297…
2026-08-01 22:54:322026-06A090652-002DEXTROAMPHETAMINE SULFATE10MGTABLET / ORAL2014-03-07a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dextroamphetamine sulfateDEXTROAMPHETAMINE SULFATEActavis Pharma, Inc.9e92ccc3-d81c-461d-a19f-7e9b582be3572026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: dextroamphetamine sulfate
generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine Sulfate Extended-ReleaseDEXTROAMPHETAMINE SULFATESpecGx LLC69c40af8-3710-46bf-bd3d-137fe5eea23e2025-12-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DEXTROAMPHETAMINE SULFATE
ZenzediDEXTROAMPHETAMINE SULFATEAzurity Pharmaceuticals, Inc.d6394df5-f2c9-47eb-b57e-f3e9cfd94f842025-11-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DEXTROAMPHETAMINE SULFATE
DEXEDRINE SPANSULEDEXTROAMPHETAMINE SULFATEAmneal Pharmaceuticals LLCcc717b9b-22ea-4c60-a1d4-ee38a40bce782025-09-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEBryant Ranch Prepack9346ff55-b751-4919-ae63-eb58b69e3f0f2025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dextroamphetamine Sulfate
generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEBryant Ranch Prepack54b122b0-2ec8-43c9-86e8-a3538a83c7762025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dextroamphetamine Sulfate
generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEBryant Ranch Prepack9f1c9cb0-7752-40cc-8ed1-5e79b8dc9da22025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dextroamphetamine Sulfate
generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEBryant Ranch Prepackfc164327-dd48-4851-b613-71d957ee60662025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dextroamphetamine Sulfate
generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEBryant Ranch Prepackb40c9a90-7e2e-48d6-adb6-2351c0ca621d2025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dextroamphetamine Sulfate
generic name: DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATESpecGx LLCe05cf690-d45a-4696-a1bf-40c9350cc0842025-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DEXTROAMPHETAMINE SULFATE
generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEWinder Laboratories LLCca1a8890-0675-4c9c-9716-6c28f975d8272025-06-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dextroamphetamine Sulfate
generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEWilshire Pharmaceuticals, Inc.6b8c97ac-c83c-4a1f-a33c-121239253abf2025-06-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dextroamphetamine Sulfate
generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATETeva Pharmaceuticals USA, Inc.ec2d13f3-d14f-47e4-abe9-7763f95a8e942025-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dextroamphetamine Sulfate
generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATECranbury Pharmaceuticals, LLC9acdf000-fefe-47c7-a44c-0f7a65c5c05c2025-05-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dextroamphetamine Sulfate
generic name: DEXTROAMPHETAMINE SULFATE
PROCENTRADEXTROAMPHETAMINE SULFATEINDEPENDENCE PHARMACEUTICALS, LLC1548cce2-fb6b-4f17-8a3b-868933f6c9d62025-05-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEPrasco Laboratories94674695-aa8a-3150-e053-2995a90a445f2025-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dextroamphetamine Sulfate
generic name: DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEBryant Ranch Prepack466cbae8-4f67-4a65-b670-ada6a953d5502025-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DEXTROAMPHETAMINE SULFATE
generic name: DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEBryant Ranch Prepack0ef920a9-c5b9-4d31-a478-ee18d22a3c5b2025-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DEXTROAMPHETAMINE SULFATE
generic name: DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATESUNRISE PHARMACEUTICAL, INC.93b3a40f-b7ac-4047-8ff5-3e34c2d751932024-12-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DEXTROAMPHETAMINE SULFATE
generic name: DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEBryant Ranch Prepackc706a849-9df6-43ca-9ac6-1d9ce6b8e8552024-09-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DEXTROAMPHETAMINE SULFATE
generic name: DEXTROAMPHETAMINE SULFATE