FDA — authorised 23 March 1943
- Application: NDA005213
- Marketing authorisation holder: GENUS
- Status: supplemented
🇺🇸 HOMATROPINE METHYLBROMIDE in United States
FDA authorised HOMATROPINE METHYLBROMIDE on 23 March 1943 · 173 US adverse-event reports
Marketing authorisations
FDA — authorised 3 March 1983
- Application: ANDA088008
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 5 July 1983
- Application: ANDA088017
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 19 July 1999
- Application: ANDA040285
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 1 December 2000
- Application: ANDA040295
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 February 2008
- Application: ANDA040613
- Marketing authorisation holder: GENUS LIFESCIENCES
- Local brand name: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 20 April 2011
- Application: ANDA091528
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 2017
- Application: ANDA203535
- Marketing authorisation holder: NOVEL LABS INC
- Status: supplemented
FDA — authorised 15 February 2017
- Application: ANDA205731
- Marketing authorisation holder: PADAGIS US
- Local brand name: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 21 February 2017
- Application: ANDA207487
- Marketing authorisation holder: ABHAI LLC
- Local brand name: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 6 March 2017
- Application: ANDA204765
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 7 August 2017
- Application: ANDA207176
- Marketing authorisation holder: AVANTHI INC
- Local brand name: HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 June 2019
- Application: ANDA210663
- Marketing authorisation holder: SANKALP LIFECARE
- Local brand name: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA
- Application: ANDA088066
- Marketing authorisation holder: HALSEY
- Local brand name: HYDROPANE
- Indication: SYRUP — ORAL
- Status: approved
FDA
- 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: 173
Most-reported reactions
- Nausea — 27 reports (15.61%)
- Cough — 20 reports (11.56%)
- Pneumonia — 20 reports (11.56%)
- Dyspnoea — 19 reports (10.98%)
- Drug Ineffective — 17 reports (9.83%)
- Vomiting — 17 reports (9.83%)
- Pain — 15 reports (8.67%)
- Fatigue — 14 reports (8.09%)
- Dizziness — 12 reports (6.94%)
- Headache — 12 reports (6.94%)
HOMATROPINE METHYLBROMIDE 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 HOMATROPINE METHYLBROMIDE approved in United States?
Yes. FDA authorised it on 23 March 1943; FDA authorised it on 3 March 1983; FDA authorised it on 5 July 1983.
Who is the marketing authorisation holder for HOMATROPINE METHYLBROMIDE in United States?
GENUS holds the US marketing authorisation.