FDA Orange Book · active-ingredient family
Desipramine hydrochloride
Desipramine hydrochloride is approved as 2 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NORPRAMIN · NDA 014399
2
Brand (NDA)
16
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NORPRAMINRLD×6 | VALIDUS PHARMS | NDA 014399 | AB | Feb 11, 1982 | |
| PERTOFRANE×2 | SANOFI AVENTIS US | NDA 013621 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (16)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DESIPRAMINE HYDROCHLORIDE×6 | ALEMBIC | ANDA 209785 | AB | Jul 07, 2021 | |
| DESIPRAMINE HYDROCHLORIDE×6 | INGENUS PHARMS LLC | ANDA 204963 | AB | Dec 26, 2017 | |
| DESIPRAMINE HYDROCHLORIDE×6 | ANI PHARMS | ANDA 205153 | — | Oct 28, 2016 | |
| DESIPRAMINE HYDROCHLORIDE×6 | HERITAGE | ANDA 207433 | — | May 05, 2016 | |
| DESIPRAMINE HYDROCHLORIDE×6 | AMNEAL PHARMS CO | ANDA 208105 | AB | Mar 17, 2016 | |
| DESIPRAMINE HYDROCHLORIDE×2 | ACTAVIS TOTOWA | ANDA 074430 | AB | Feb 09, 1996 | |
| DESIPRAMINE HYDROCHLORIDE×6 | CHARTWELL RX | ANDA 072103 | AB | May 24, 1988 | |
| DESIPRAMINE HYDROCHLORIDE×5 | ANI PHARMS | ANDA 071803 | — | Dec 08, 1987 | |
| DESIPRAMINE HYDROCHLORIDE | ACTAVIS TOTOWA | ANDA 071602 | AB | Oct 05, 1987 | |
| DESIPRAMINE HYDROCHLORIDE | ACTAVIS TOTOWA | ANDA 071766 | AB | Oct 05, 1987 | |
| DESIPRAMINE HYDROCHLORIDE | USL PHARMA | ANDA 071864 | — | Sep 09, 1987 | |
| DESIPRAMINE HYDROCHLORIDE | USL PHARMA | ANDA 071865 | — | Sep 09, 1987 | |
| DESIPRAMINE HYDROCHLORIDE | USL PHARMA | ANDA 071866 | — | Sep 09, 1987 | |
| DESIPRAMINE HYDROCHLORIDE | USL PHARMA | ANDA 071867 | — | Sep 09, 1987 | |
| DESIPRAMINE HYDROCHLORIDE | ACTAVIS TOTOWA | ANDA 071601 | AB | Jun 05, 1987 | |
| DESIPRAMINE HYDROCHLORIDE | ACTAVIS TOTOWA | ANDA 071588 | AB | Jun 05, 1987 |
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.
Desipramine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
