FDA Orange Book · active-ingredient family
Amphetamine adipate; amphetamine sulfate; dextroamphetamine adipate; dextroamphetamine sulfate
Amphetamine adipate; amphetamine sulfate; dextroamphetamine adipate; dextroamphetamine sulfate: 0 brands, 2 generics; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available — 2 ANDA applications approved.
Brands (NDA)
0
Generics (ANDA)
2
Listed patents
0
Presentations
8
Abbreviated applications
Generic (ANDA) products (2)
TEVAANDA 083564—4 strengths
TEVAANDA 083564—4 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | ORAL | Discontinued | — |
| 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | ORAL | Discontinued | — |
| 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | ORAL | Discontinued | — |
| 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | ORAL | Discontinued | — |
TEVAANDA 083563—4 strengths
TEVAANDA 083563—4 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
| 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
| 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
| 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
Orange Book patent file
Listed patents
Listed patents
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.
Amphetamine adipate; amphetamine sulfate; dextroamphetamine adipate; 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 BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
