FDA — authorised 5 October 1987
- Application: ANDA071766
- Marketing authorisation holder: ACTAVIS TOTOWA
- Local brand name: DESIPRAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 DESIPRAMINE HYDROCHLORIDE in United States
FDA authorised DESIPRAMINE HYDROCHLORIDE on 5 October 1987 · 123 US adverse-event reports
Marketing authorisations
FDA — authorised 20 June 1988
- Application: ANDA072103
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: DESIPRAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 June 1989
- Application: NDA014399
- Marketing authorisation holder: VALIDUS PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 9 February 1996
- Application: ANDA074430
- Marketing authorisation holder: ACTAVIS TOTOWA
- Local brand name: DESIPRAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 May 1997
- Application: ANDA071803
- Marketing authorisation holder: ANI PHARMS
- Local brand name: DESIPRAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 March 2016
- Application: ANDA208105
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: DESIPRAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 May 2016
- Application: ANDA207433
- Marketing authorisation holder: HERITAGE
- Local brand name: DESIPRAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 2016
- Application: ANDA205153
- Marketing authorisation holder: ANI PHARMS
- Local brand name: DESIPRAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 December 2017
- Application: ANDA204963
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: DESIPRAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 July 2021
- Application: ANDA209785
- Marketing authorisation holder: ALEMBIC
- Local brand name: DESIPRAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 September 2024
- Application: ANDA071588
- Marketing authorisation holder: ACTAVIS TOTOWA
- Indication: Labeling
- Status: approved
The FDA approved DESIPRAMINE HYDROCHLORIDE, manufactured by ACTAVIS TOTOWA, on 6 September 2024. The approval was granted under the standard expedited pathway. The drug's indication is listed as 'Labeling', but the specific indication is not specified. This approval was granted based on an ANDA (Abbreviated New Drug Application) with the application number ANDA071588.
FDA
- Application: ANDA071864
- Marketing authorisation holder: USL PHARMA
- Local brand name: DESIPRAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071867
- Marketing authorisation holder: USL PHARMA
- Local brand name: DESIPRAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071865
- Marketing authorisation holder: USL PHARMA
- Local brand name: DESIPRAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071866
- Marketing authorisation holder: USL PHARMA
- Local brand name: DESIPRAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 123
Most-reported reactions
- Drug Ineffective — 16 reports (13.01%)
- Toxicity To Various Agents — 16 reports (13.01%)
- Fatigue — 13 reports (10.57%)
- Off Label Use — 13 reports (10.57%)
- Nausea — 12 reports (9.76%)
- Completed Suicide — 11 reports (8.94%)
- Confusional State — 11 reports (8.94%)
- Headache — 11 reports (8.94%)
- Depression — 10 reports (8.13%)
- Drug Hypersensitivity — 10 reports (8.13%)
DESIPRAMINE HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is DESIPRAMINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 5 October 1987; FDA authorised it on 20 June 1988; FDA authorised it on 19 June 1989.
Who is the marketing authorisation holder for DESIPRAMINE HYDROCHLORIDE in United States?
ACTAVIS TOTOWA holds the US marketing authorisation.