FDA Orange Book · active-ingredient family
Desipramine hydrochloride
Desipramine hydrochloride: 2 brands, 16 generics; first approved Feb 11, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 16 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
16
Listed patents
0
Presentations
59
Brand (NDA) products
Originator applications
- NORPRAMINRLDVALIDUS PHARMSNDA 01439919826 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - SANOFI AVENTIS USNDA 013621—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued —
Generic (ANDA) products (16)
Abbreviated applications
- DESIPRAMINE HYDROCHLORIDEALEMBICANDA 20978520216 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - DESIPRAMINE HYDROCHLORIDEINGENUS PHARMS LLCANDA 20496320176 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - DESIPRAMINE HYDROCHLORIDEANI PHARMSANDA 20515320166 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — - DESIPRAMINE HYDROCHLORIDEHERITAGEANDA 20743320166 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — - DESIPRAMINE HYDROCHLORIDEAMNEAL PHARMS COANDA 20810520166 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - DESIPRAMINE HYDROCHLORIDEACTAVIS TOTOWAANDA 07443019962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - DESIPRAMINE HYDROCHLORIDECHARTWELL RXANDA 07210319886 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - DESIPRAMINE HYDROCHLORIDEANI PHARMSANDA 07180319875 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — - DESIPRAMINE HYDROCHLORIDEACTAVIS TOTOWAANDA 0716021987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB - DESIPRAMINE HYDROCHLORIDEACTAVIS TOTOWAANDA 0717661987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB - DESIPRAMINE HYDROCHLORIDEUSL PHARMAANDA 0718641987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - DESIPRAMINE HYDROCHLORIDEUSL PHARMAANDA 0718651987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - DESIPRAMINE HYDROCHLORIDEUSL PHARMAANDA 0718661987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - DESIPRAMINE HYDROCHLORIDEUSL PHARMAANDA 0718671987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - DESIPRAMINE HYDROCHLORIDEACTAVIS TOTOWAANDA 0716011987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - DESIPRAMINE HYDROCHLORIDEACTAVIS TOTOWAANDA 0715881987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB
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
45 yr 2 mo ago
Most recent approval
5 yr 2 mo ago
Approvals span 1982–2021 across 18 FDA applications.
Brand (NDA) 211%
Generic (ANDA) 1689%
Desipramine 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.
