FDA — authorised 28 June 2010
- Application: ANDA078944
- Marketing authorisation holder: KENTON
- Local brand name: ANASTROZOLE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 ANASTROZOLE in United States
FDA authorised ANASTROZOLE on 28 June 2010 · 14,000 US adverse-event reports
Marketing authorisations
FDA — authorised 28 June 2010
- Application: ANDA079220
- Marketing authorisation holder: NATCO PHARMA LTD
- Local brand name: ANASTROZOLE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved ANASTROZOLE for marketing in the United States on 2025-07-15. The approval was granted to NATCO PHARMA LTD, with the application number ANDA079220. ANASTROZOLE is approved for the indication specified in its labelling, but the specific indication is not reported in the available data.
FDA — authorised 28 June 2010
- Application: ANDA078058
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: ANASTROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 2010
- Application: ANDA079007
- Marketing authorisation holder: SANDOZ
- Local brand name: ANASTROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 2010
- Application: ANDA078921
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: ANASTROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 2010
- Application: ANDA090568
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: ANASTROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 2010
- Application: ANDA078984
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: ANASTROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 2010
- Application: ANDA090088
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: ANASTROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 2010
- Application: ANDA091164
- Marketing authorisation holder: CIPLA
- Local brand name: ANASTROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 January 2011
- Application: ANDA091331
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: ANASTROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 April 2011
- Application: NDA020541
- Marketing authorisation holder: ANI PHARMS
- Indication: Efficacy
- Status: approved
FDA — authorised 15 July 2011
- Application: ANDA091177
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: ANASTROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 May 2012
- Application: ANDA200654
- Marketing authorisation holder: APOTEX INC
- Local brand name: ANASTROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2012
- Application: ANDA091242
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: ANASTROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 November 2018
- Application: ANDA206037
- Marketing authorisation holder: BEIJING YILING
- Local brand name: ANASTROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 July 2020
- Application: ANDA212434
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: ANASTROZOLE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved ANASTROZOLE for marketing in the United States on 24 October 2025. The approval was granted to EUGIA PHARMA under the standard expedited pathway. The application number for this approval is ANDA212434.
FDA
- Application: ANDA078322
- Marketing authorisation holder: SYNTHON PHARMS
- Local brand name: ANASTROZOLE
- 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: 14,000
Most-reported reactions
- Fatigue — 2,239 reports (15.99%)
- Nausea — 1,804 reports (12.89%)
- Diarrhoea — 1,723 reports (12.31%)
- Arthralgia — 1,582 reports (11.3%)
- Alopecia — 1,418 reports (10.13%)
- Headache — 1,154 reports (8.24%)
- Dyspnoea — 1,066 reports (7.61%)
- Asthenia — 1,025 reports (7.32%)
- Malignant Neoplasm Progression — 1,002 reports (7.16%)
- Pain — 987 reports (7.05%)
ANASTROZOLE 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 ANASTROZOLE approved in United States?
Yes. FDA authorised it on 28 June 2010; FDA authorised it on 28 June 2010; FDA authorised it on 28 June 2010.
Who is the marketing authorisation holder for ANASTROZOLE in United States?
KENTON holds the US marketing authorisation.