FDA — authorised 29 December 1989
- Application: NDA019906
- Marketing authorisation holder: SPECGX LLC
- Indication: Labeling
- Status: approved
🇺🇸 CLOMIPRAMINE HYDROCHLORIDE in United States
FDA authorised CLOMIPRAMINE HYDROCHLORIDE on 29 December 1989 · 481 US adverse-event reports
Marketing authorisations
FDA — authorised 29 March 1996
- Application: ANDA074364
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 November 1996
- Application: ANDA074600
- Marketing authorisation holder: WATSON LABS
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 December 1996
- Application: ANDA074694
- Marketing authorisation holder: TARO
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 April 1997
- Application: ANDA074849
- Marketing authorisation holder: TEVA
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 June 1997
- Application: ANDA074953
- Marketing authorisation holder: SANDOZ
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 August 1997
- Application: ANDA074958
- Marketing authorisation holder: TEVA
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 April 1998
- Application: ANDA074947
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 September 1998
- Application: ANDA074751
- Marketing authorisation holder: WATSON LABS
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 December 2017
- Application: ANDA208961
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 October 2018
- Application: ANDA208632
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 November 2018
- Application: ANDA209294
- Marketing authorisation holder: LUPIN
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 April 2019
- Application: ANDA211767
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 October 2019
- Application: ANDA212218
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 February 2020
- Application: ANDA211364
- Marketing authorisation holder: IXORA LIFESCIENCE
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 April 2020
- Application: ANDA210653
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 June 2020
- Application: ANDA213219
- Marketing authorisation holder: MICRO LABS
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 June 2020
- Application: ANDA213221
- Marketing authorisation holder: RK PHARMA
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 August 2020
- Application: ANDA212285
- Marketing authorisation holder: UNIQUE
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 October 2020
- Application: ANDA213897
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 August 2021
- Application: ANDA211822
- Marketing authorisation holder: ALEMBIC
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 March 2023
- Application: ANDA216440
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: CLOMIPRAMINE HYDROCHLORIDE
- Indication: CAPSULE — 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: 481
Most-reported reactions
- Coma — 68 reports (14.14%)
- Drug Ineffective — 58 reports (12.06%)
- Drug Interaction — 56 reports (11.64%)
- Toxicity To Various Agents — 49 reports (10.19%)
- Off Label Use — 45 reports (9.36%)
- Somnolence — 45 reports (9.36%)
- Suicide Attempt — 45 reports (9.36%)
- Intentional Overdose — 40 reports (8.32%)
- Electrocardiogram Qt Prolonged — 38 reports (7.9%)
- Vomiting — 37 reports (7.69%)
CLOMIPRAMINE 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 CLOMIPRAMINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 29 December 1989; FDA authorised it on 29 March 1996; FDA authorised it on 27 November 1996.
Who is the marketing authorisation holder for CLOMIPRAMINE HYDROCHLORIDE in United States?
SPECGX LLC holds the US marketing authorisation.