FDA — authorised 30 September 1997
- Application: NDA020757
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: AVAPRO
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Avapro in United States
FDA authorised Avapro on 30 September 1997
Marketing authorisations
FDA — authorised 30 September 1997
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
FDA — authorised 30 March 2012
- Application: ANDA077159
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2012
- Application: ANDA203161
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2012
- Application: ANDA203081
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2012
- Application: ANDA079213
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2012
- Application: ANDA202910
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2012
- Application: ANDA200461
- Marketing authorisation holder: YILING
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2012
- Application: ANDA203071
- Marketing authorisation holder: PRINSTON INC
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2012
- Application: ANDA077466
- Marketing authorisation holder: SANDOZ
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 October 2012
- Application: ANDA202254
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 2012
- Application: ANDA200832
- Marketing authorisation holder: APOTEX INC
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 2012
- Application: ANDA091236
- Marketing authorisation holder: ALEMBIC PHARMS LTD
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 2012
- Application: ANDA090201
- Marketing authorisation holder: HIKMA
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 2012
- Application: ANDA201531
- Marketing authorisation holder: LUPIN LTD
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 November 2012
- Application: ANDA077205
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 December 2015
- Application: ANDA204774
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 December 2015
- Application: ANDA203020
- Marketing authorisation holder: UNICHEM
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 2015
- Application: ANDA203685
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 April 2018
- Application: ANDA204740
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 May 2024
- Application: ANDA211056
- Marketing authorisation holder: IPCA LABS LTD
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 November 2025
- Application: ANDA219539
- Marketing authorisation holder: MSN
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
Avapro in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Avapro approved in United States?
Yes. FDA authorised it on 30 September 1997; FDA authorised it on 30 September 1997; FDA authorised it on 30 March 2012.
Who is the marketing authorisation holder for Avapro in United States?
SANOFI AVENTIS US holds the US marketing authorisation.