FDA — authorised 31 October 1986
- Application: NDA019221
- Marketing authorisation holder: BAUSCH
- Local brand name: VASERETIC
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Vasotec in United States
FDA authorised Vasotec on 31 October 1986
Marketing authorisations
FDA — authorised 27 December 1996
- Application: NDA020668
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: LEXXEL
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075479
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075480
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075048
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075482
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075370
- Marketing authorisation holder: KRKA DD NOVO MESTO
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075621
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075483
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075496
- Marketing authorisation holder: SANDOZ INC
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075459
- Marketing authorisation holder: SANDOZ INC
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075472
- Marketing authorisation holder: MYLAN
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075583
- Marketing authorisation holder: APOTHECON
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075556
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075501
- Marketing authorisation holder: WATSON LABS
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 August 2000
- Application: ANDA075369
- Marketing authorisation holder: KRKA DD NOVO MESTO
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 January 2001
- Application: ANDA075657
- Marketing authorisation holder: TARO
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 March 2001
- Application: ANDA075178
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 September 2001
- Application: ANDA075788
- Marketing authorisation holder: TARO PHARM INDS
- Local brand name: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 September 2001
- Application: ANDA075624
- Marketing authorisation holder: RISING
- Local brand name: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 September 2001
- Application: ANDA076116
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 2001
- Application: ANDA075909
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 March 2003
- Application: ANDA075736
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 October 2004
- Application: ANDA076486
- Marketing authorisation holder: MPP PHARMA
- Local brand name: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 August 2021
- Application: ANDA212408
- Marketing authorisation holder: BIONPHARMA
- Local brand name: ENALAPRIL MALEATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 24 February 2022
- Application: ANDA214467
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: ENALAPRIL MALEATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 30 March 2022
- Application: ANDA213714
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: ENALAPRIL MALEATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 29 June 2022
- Application: ANDA212894
- Marketing authorisation holder: AMNEAL
- Local brand name: ENALAPRIL MALEATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 7 July 2022
- Application: ANDA213273
- Marketing authorisation holder: PRINSTON INC
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 January 2024
- Application: ANDA216458
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ENALAPRIL MALEATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 19 September 2024
- Application: ANDA218531
- Marketing authorisation holder: UNIQUE PHARM
- Local brand name: ENALAPRIL MALEATE
- Indication: TABLET — ORAL
- Status: approved
Vasotec in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Vasotec approved in United States?
Yes. FDA authorised it on 31 October 1986; FDA authorised it on 27 December 1996; FDA authorised it on 22 August 2000.
Who is the marketing authorisation holder for Vasotec in United States?
BAUSCH holds the US marketing authorisation.