FDA Orange Book · active-ingredient family
Diethylpropion hydrochloride
Diethylpropion hydrochloride: 6 brands, 10 generics; first approved Aug 25, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 10 ANDA applications approved.
Brands (NDA)
6
Generics (ANDA)
10
Listed patents
0
Presentations
16
Brand (NDA) products
Originator applications
- ANI PHARMSNDA 012546—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET, EXTENDED RELEASE ORAL Discontinued — - TENUATERLDMPP PHARMANDA 011722—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - SANOFI AVENTIS USNDA 017669—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET, EXTENDED RELEASE ORAL Discontinued — - 3MNDA 017956—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET, EXTENDED RELEASE ORAL Discontinued — - SANOFI AVENTIS USNDA 017668—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - 3MNDA 011673—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued —
Generic (ANDA) products (10)
Abbreviated applications
- DIETHYLPROPION HYDROCHLORIDERSLANNETT CO INCANDA 0916802011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET, EXTENDED RELEASE ORAL Rx — - DIETHYLPROPION HYDROCHLORIDERSLANNETT CO INCANDA 2001772011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AA - DIETHYLPROPION HYDROCHLORIDEAVANTHI INCANDA 2012122010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AA - DIETHYLPROPION HYDROCHLORIDEEPIC PHARMA LLCANDA 0408282008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - DIETHYLPROPION HYDROCHLORIDETEVAANDA 0886421984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - DIETHYLPROPION HYDROCHLORIDECHARTWELL RXANDA 0882671983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - DIETHYLPROPION HYDROCHLORIDECHARTWELL RXANDA 0882681983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - DIETHYLPROPION HYDROCHLORIDESANDOZANDA 085916—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - DIETHYLPROPION HYDROCHLORIDEUCB INCANDA 085544—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - DIETHYLPROPION HYDROCHLORIDEWATSON LABSANDA 085741—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG 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
43 yr 7 mo ago
Most recent approval
15 yr ago
Approvals span 1983–2011 across 16 FDA applications.
Brand (NDA) 638%
Generic (ANDA) 1063%
Diethylpropion 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.
