FDA — authorised 31 January 1972
- Application: NDA016987
- Marketing authorisation holder: NEW RIVER
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 DOXEPIN HYDROCHLORIDE in United States
FDA authorised DOXEPIN HYDROCHLORIDE on 31 January 1972 · 1,578 US adverse-event reports
Marketing authorisations
FDA — authorised 13 May 1986
- Application: ANDA070792
- Marketing authorisation holder: MYLAN
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 May 1986
- Application: ANDA070790
- Marketing authorisation holder: MYLAN
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 May 1986
- Application: ANDA070791
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 May 1986
- Application: ANDA070793
- Marketing authorisation holder: MYLAN
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 May 1986
- Application: ANDA070825
- Marketing authorisation holder: SANDOZ
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 May 1986
- Application: ANDA070828
- Marketing authorisation holder: SANDOZ
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 May 1986
- Application: ANDA070827
- Marketing authorisation holder: SANDOZ
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 March 1987
- Application: ANDA071487
- Marketing authorisation holder: SANDOZ
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 March 1987
- Application: ANDA071562
- Marketing authorisation holder: SANDOZ
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 April 1987
- Application: ANDA071326
- Marketing authorisation holder: WATSON LABS
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 April 1987
- Application: ANDA071485
- Marketing authorisation holder: WATSON LABS
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 April 1987
- Application: ANDA071486
- Marketing authorisation holder: WATSON LABS
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 November 1987
- Application: ANDA071422
- Marketing authorisation holder: PH HEALTH
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 November 1987
- Application: ANDA071437
- Marketing authorisation holder: PAR PHARM
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 1988
- Application: ANDA071654
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 1988
- Application: ANDA071653
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 1988
- Application: ANDA071502
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 1988
- Application: ANDA071521
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 July 1988
- Application: ANDA071918
- Marketing authorisation holder: PHARMOBEDIENT CNSLTG
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 28 December 1990
- Application: ANDA073055
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 December 1990
- Application: ANDA073054
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 March 1991
- Application: ANDA072986
- Marketing authorisation holder: WATSON LABS
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 March 1991
- Application: ANDA072987
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 March 1991
- Application: ANDA072985
- Marketing authorisation holder: WATSON LABS
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 December 1998
- Application: ANDA074721
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 15 January 2004
- Application: ANDA075924
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 26 July 2013
- Application: ANDA201951
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 January 2016
- Application: ANDA202337
- Marketing authorisation holder: RK PHARMA
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 2017
- Application: ANDA207482
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 March 2019
- Application: ANDA211603
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 September 2019
- Application: ANDA212624
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 July 2020
- Application: ANDA202510
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 July 2020
- Application: ANDA212997
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 July 2020
- Application: ANDA213474
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 October 2020
- Application: ANDA210675
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 March 2021
- Application: ANDA211618
- Marketing authorisation holder: VELZEN PHARMA PVT
- Status: approved
FDA — authorised 9 March 2021
- Application: ANDA211619
- Marketing authorisation holder: IXORA LIFESCIENCE
- Status: approved
FDA — authorised 1 April 2021
- Application: ANDA214908
- Marketing authorisation holder: APPCO
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 February 2022
- Application: ANDA215710
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 April 2022
- Application: ANDA213796
- Marketing authorisation holder: ADAPTIS
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 June 2022
- Application: ANDA215113
- Marketing authorisation holder: MSN
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 February 2023
- Application: ANDA215408
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 21 March 2023
- Application: ANDA210140
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 March 2023
- Application: ANDA210700
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 April 2023
- Application: ANDA214823
- Marketing authorisation holder: MSN
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 June 2023
- Application: ANDA217688
- Marketing authorisation holder: MICRO LABS
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 August 2023
- Application: ANDA212357
- Marketing authorisation holder: AMNEAL
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 21 August 2023
- Application: ANDA217975
- Marketing authorisation holder: UNIQUE
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 July 2024
- Application: ANDA216041
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 August 2025
- Application: ANDA219058
- Marketing authorisation holder: TARO
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 2026
- Application: ANDA213919
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CREAM — TOPICAL
- Status: approved
The FDA approved SUN PHARMA CANADA's application (ANDA213919) for DOXEPIN HYDROCHLORIDE cream, a topical medication. This approval was granted on 28 April 2026. The approved indication is for the treatment of various skin conditions using a topical cream formulation of doxepin hydrochloride.
FDA
- Application: ANDA070954
- Marketing authorisation holder: WATSON LABS
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070953
- Marketing authorisation holder: WATSON LABS
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070952
- Marketing authorisation holder: WATSON LABS
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070973
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070972
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA072375
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA071764
- Marketing authorisation holder: WATSON LABS
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072376
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA071763
- Marketing authorisation holder: WATSON LABS
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072386
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072387
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072110
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072109
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA071686
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA071685
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA071676
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA071675
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA071674
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA071673
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: DOXEPIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070955
- Marketing authorisation holder: WATSON LABS
- Local brand name: DOXEPIN 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: 1,578
Most-reported reactions
- Completed Suicide — 184 reports (11.66%)
- Pain — 184 reports (11.66%)
- Drug Ineffective — 175 reports (11.09%)
- Dizziness — 162 reports (10.27%)
- Insomnia — 157 reports (9.95%)
- Toxicity To Various Agents — 152 reports (9.63%)
- Fall — 150 reports (9.51%)
- Anxiety — 146 reports (9.25%)
- Fatigue — 144 reports (9.13%)
- Off Label Use — 124 reports (7.86%)
DOXEPIN 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 DOXEPIN HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 31 January 1972; FDA authorised it on 13 May 1986; FDA authorised it on 13 May 1986.
Who is the marketing authorisation holder for DOXEPIN HYDROCHLORIDE in United States?
NEW RIVER holds the US marketing authorisation.