FDA Orange Book · active-ingredient family
Benzphetamine hydrochloride
Benzphetamine hydrochloride: 1 brand, 9 generics; first approved Apr 17, 2006; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
9
Listed patents
0
Presentations
13
Brand (NDA) products
Originator applications
- DIDREXRLDPFIZERNDA 012427—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued —
Generic (ANDA) products (9)
Abbreviated applications
- BENZPHETAMINE HYDROCHLORIDEEPIC PHARMA LLCANDA 0903462015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AA - BENZPHETAMINE HYDROCHLORIDETEDOR PHARMANDA 04074720152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — - BENZPHETAMINE HYDROCHLORIDEAVET LIFESCIENCESANDA 2020612012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AA - BENZPHETAMINE HYDROCHLORIDECHARTWELLANDA 09047320102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx — 50MG TABLET ORAL Rx AA - BENZPHETAMINE HYDROCHLORIDERSKVK TECHANDA 0909682010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AA - BENZPHETAMINE HYDROCHLORIDEIMPAX LABSANDA 0408452008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - BENZPHETAMINE HYDROCHLORIDEEPIC PHARMA LLCANDA 0407142007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - BENZPHETAMINE HYDROCHLORIDESPECGX LLCANDA 0407732007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - BENZPHETAMINE HYDROCHLORIDESCINOPHARM TAIWANANDA 0405782006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG 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
20 yr 8 mo ago
Most recent approval
10 yr 10 mo ago
Approvals span 2006–2015 across 10 FDA applications.
Brand (NDA) 110%
Generic (ANDA) 990%
Benzphetamine hydrochloride: 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.
