FDA — authorised 29 December 2005
- Application: ANDA076310
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: CABERGOLINE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Letrozole tablets in United States
FDA authorised Letrozole tablets on 29 December 2005 · 29 US adverse-event reports
Marketing authorisations
FDA — authorised 7 March 2007
- Application: ANDA077750
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CABERGOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 April 2008
- Application: ANDA078035
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: CABERGOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 March 2013
- Application: ANDA201503
- Marketing authorisation holder: APOTEX CORP
- Local brand name: CABERGOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 December 2013
- Application: ANDA202947
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CABERGOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 August 2018
- Application: ANDA204735
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: CABERGOLINE
- Indication: TABLET — 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: 29
Most-reported reactions
- Arthralgia — 4 reports (13.79%)
- Neutropenia — 4 reports (13.79%)
- Condition Aggravated — 3 reports (10.34%)
- Drug Ineffective — 3 reports (10.34%)
- Fatigue — 3 reports (10.34%)
- Nausea — 3 reports (10.34%)
- Product Quality Issue — 3 reports (10.34%)
- Anaemia — 2 reports (6.9%)
- Drug-Induced Liver Injury — 2 reports (6.9%)
- Keloid Scar — 2 reports (6.9%)
Letrozole tablets 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 Letrozole tablets approved in United States?
Yes. FDA authorised it on 29 December 2005; FDA authorised it on 7 March 2007; FDA authorised it on 21 April 2008.
Who is the marketing authorisation holder for Letrozole tablets in United States?
STRIDES PHARMA INTL holds the US marketing authorisation.