FDA Orange Book · active-ingredient family
Dextroamphetamine sulfate
Dextroamphetamine sulfate: 1 brand, 39 generics; first approved May 13, 1999; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 39 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
39
Listed patents
0
Presentations
82
Brand (NDA) products
Originator applications
- IMPAX LABS INCNDA 017078—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 15MG CAPSULE, EXTENDED RELEASE ORAL Rx AB
Generic (ANDA) products (39)
Abbreviated applications
- DEXTROAMPHETAMINE SULFATETRIS PHARMA INCANDA 20609520222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DEXTROAMPHETAMINE SULFATEWINDER LABS LLCANDA 21216020217 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AA 5MG TABLET ORAL Rx AA 7.5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA 15MG TABLET ORAL Rx AA 20MG TABLET ORAL Rx AA 30MG TABLET ORAL Rx AA - DEXTROAMPHETAMINE SULFATESTRIDES PHARMAANDA 20507720193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 10MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 15MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DEXTROAMPHETAMINE SULFATESTRIDES PHARMA INTLANDA 20567320173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 10MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 15MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DEXTROAMPHETAMINE SULFATENUVO PHARMANDA 21005920172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - DEXTROAMPHETAMINE SULFATENESHER PHARMSANDA 20911120173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 10MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 15MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DEXTROAMPHETAMINE SULFATENESHER PHARMSANDA 20658820162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DEXTROAMPHETAMINE SULFATENOVEL LABS INCANDA 20433020162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - DEXTROAMPHETAMINE SULFATEQUAGENANDA 20673520163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 10MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 15MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DEXTROAMPHETAMINE SULFATEAVANTHI INCANDA 20354820152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - DEXTROAMPHETAMINE SULFATEEPIC PHARMA LLCANDA 09065220142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DEXTROAMPHETAMINE SULFATEAUROLIFE PHARMA LLCANDA 20289320132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - DEXTROAMPHETAMINE SULFATETRIS PHARMA INCANDA 2036442013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx AA - DEXTROAMPHETAMINE SULFATEACTAVIS ELIZABETHANDA 20390120123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 15MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - DEXTROAMPHETAMINE SULFATEAZURITYANDA 09053320117 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AA 5MG TABLET ORAL Rx AA 7.5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA 15MG TABLET ORAL Rx AA 20MG TABLET ORAL Rx AA 30MG TABLET ORAL Rx AA - DEXTROAMPHETAMINE SULFATERSPRASCOANDA 0407762008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx AA - DEXTROAMPHETAMINE SULFATEABLEANDA 07681420043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 10MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 15MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DEXTROAMPHETAMINE SULFATESPECGX LLCANDA 07635320033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 15MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - DEXTROAMPHETAMINE SULFATENESHER PHARMSANDA 0403652002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - DEXTROAMPHETAMINE SULFATENESHER PHARMSANDA 0403672002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - DEXTROAMPHETAMINE SULFATESPECGX LLCANDA 04043620022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - DEXTROAMPHETAMINE SULFATESENORES PHARMSANDA 07613720023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 10MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 15MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DEXTROAMPHETAMINE SULFATEBARRANDA 04036120012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - DEXTROAMPHETAMINE SULFATESTRIDES PHARMA INTLANDA 0402991999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - TEVAANDA 085355—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued — - GLAXOSMITHKLINEANDA 083902—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML ELIXIR ORAL Discontinued — - TEVAANDA 083735—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DEXEDRINERLDGLAXOSMITHKLINEANDA 084935—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - DEXTROAMPHETAMINE SULFATEANI PHARMSANDA 085370—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - DEXTROAMPHETAMINE SULFATEHALSEYANDA 083930—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - DEXTROAMPHETAMINE SULFATELANNETTANDA 083903—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DEXTROAMPHETAMINE SULFATELANNETTANDA 085652—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — - DEXTROAMPHETAMINE SULFATEMAST MMANDA 086521—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - DEXTROAMPHETAMINE SULFATEPUREPAC PHARMANDA 084125—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - DEXTROAMPHETAMINE SULFATESANDOZANDA 085371—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - DEXTROAMPHETAMINE SULFATEVITARINEANDA 084986—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - DEXTROAMPHETAMINE SULFATEVITARINEANDA 085892—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - DEXTROSTATRLDSHIREANDA 084051—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - FERNDALE LABSANDA 084001—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
27 yr 8 mo ago
Most recent approval
4 yr 1 mo ago
Approvals span 1999–2022 across 40 FDA applications.
Brand (NDA) 13%
Generic (ANDA) 3998%
Dextroamphetamine sulfate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
