FDA — authorised 17 March 2000
- Application: NDA021124
- Marketing authorisation holder: KARO HLTHCARE
- Local brand name: LAMISIL AT
- Indication: SPRAY — TOPICAL
- Status: approved
🇺🇸 TERBINAFINE HYDROCHLORIDE in United States
FDA authorised TERBINAFINE HYDROCHLORIDE on 17 March 2000 · 678 US adverse-event reports
Marketing authorisations
FDA — authorised 2 July 2007
- Application: ANDA076390
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: TERBINAFINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 July 2007
- Application: ANDA077137
- Marketing authorisation holder: CIPLA
- Local brand name: TERBINAFINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 July 2007
- Application: ANDA077511
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: TERBINAFINE HYDROCHLORIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 2 July 2007
- Application: ANDA076377
- Marketing authorisation holder: HERITAGE PHARMA AVET
- Local brand name: TERBINAFINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 July 2007
- Application: ANDA078297
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: TERBINAFINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 July 2007
- Application: ANDA078157
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: TERBINAFINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 July 2007
- Application: ANDA078163
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: TERBINAFINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 July 2007
- Application: ANDA077195
- Marketing authorisation holder: NATCO PHARMA
- Local brand name: TERBINAFINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 July 2007
- Application: ANDA077533
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: TERBINAFINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 July 2007
- Application: ANDA077919
- Marketing authorisation holder: EMED MEDCL
- Local brand name: TERBINAFINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 July 2007
- Application: ANDA078229
- Marketing authorisation holder: WOCKHARDT
- Local brand name: TERBINAFINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 June 2010
- Application: ANDA077714
- Marketing authorisation holder: BRECKENRIDGE PHARM
- Local brand name: TERBINAFINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA077065
- Marketing authorisation holder: GEDEON RICHTER USA
- Local brand name: TERBINAFINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA077136
- Marketing authorisation holder: MYLAN
- Local brand name: TERBINAFINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA077223
- Marketing authorisation holder: ROXANE
- Local brand name: TERBINAFINE 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: 678
Most-reported reactions
- Drug Ineffective — 96 reports (14.16%)
- Pruritus — 79 reports (11.65%)
- Rash — 77 reports (11.36%)
- Nausea — 75 reports (11.06%)
- Ageusia — 66 reports (9.73%)
- Fatigue — 64 reports (9.44%)
- Pain — 61 reports (9%)
- Dyspnoea — 54 reports (7.96%)
- Dysgeusia — 53 reports (7.82%)
- Weight Decreased — 53 reports (7.82%)
TERBINAFINE 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 TERBINAFINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 17 March 2000; FDA authorised it on 2 July 2007; FDA authorised it on 2 July 2007.
Who is the marketing authorisation holder for TERBINAFINE HYDROCHLORIDE in United States?
KARO HLTHCARE holds the US marketing authorisation.