FDA — authorised 14 November 2003
- Application: NDA021507
- Marketing authorisation holder: TAKEDA PHARMS NA
- Local brand name: PREVACID NAPRAPAC 250 (COPACKAGED)
- Indication: CAPSULE, DELAYED REL PELLETS, TABLET — ORAL
- Status: approved
🇺🇸 Proton pump inhibitor in United States
FDA authorised Proton pump inhibitor on 14 November 2003
Marketing authorisations
FDA — authorised 27 May 2004
- Application: NDA021566
- Marketing authorisation holder: TAKEDA PHARMS NA
- Local brand name: PREVACID IV
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 18 May 2009
- Application: NDA022327
- Marketing authorisation holder: PERRIGO PHARMA INTL
- Local brand name: PREVACID 24 HR
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 10 November 2009
- Application: ANDA077255
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 10 November 2009
- Application: ANDA090763
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 23 April 2010
- Application: ANDA090331
- Marketing authorisation holder: SANDOZ
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 15 October 2010
- Application: ANDA078730
- Marketing authorisation holder: ANI PHARMS
- Local brand name: LANSOPRAZOLE
- Indication: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 15 October 2010
- Application: ANDA091269
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 18 May 2012
- Application: ANDA202319
- Marketing authorisation holder: PERRIGO R AND D
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 18 May 2012
- Application: ANDA202727
- Marketing authorisation holder: GLENMARK PHARMS
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 18 May 2012
- Application: ANDA202194
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 14 September 2012
- Application: ANDA202176
- Marketing authorisation holder: APOTEX
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 18 December 2012
- Application: ANDA201921
- Marketing authorisation holder: NATCO PHARMA LTD
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 19 August 2013
- Application: ANDA202366
- Marketing authorisation holder: ZYDUS HLTHCARE
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 30 August 2013
- Application: ANDA200218
- Marketing authorisation holder: ANI PHARMS
- Local brand name: LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
- Indication: CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 13 September 2013
- Application: ANDA091509
- Marketing authorisation holder: SUN PHARM
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 13 September 2013
- Application: ANDA202637
- Marketing authorisation holder: SUN PHARM
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 16 September 2013
- Application: ANDA091212
- Marketing authorisation holder: KRKA TOVARNA ZDRAVIL
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 4 March 2014
- Application: ANDA202588
- Marketing authorisation holder: SANDOZ
- Local brand name: LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
- Indication: CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 13 January 2016
- Application: ANDA203306
- Marketing authorisation holder: NATCO
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 1 June 2016
- Application: ANDA203187
- Marketing authorisation holder: MYLAN
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 7 June 2016
- Application: NDA208025
- Marketing authorisation holder: DEXCEL
- Local brand name: LANSOPRAZOLE
- Indication: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 25 July 2016
- Application: ANDA203203
- Marketing authorisation holder: XIROMED
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 7 October 2016
- Application: ANDA206006
- Marketing authorisation holder: RISING
- Local brand name: LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
- Indication: CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 14 October 2016
- Application: ANDA203957
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 30 August 2017
- Application: ANDA205868
- Marketing authorisation holder: INVENTIA
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 21 September 2017
- Application: ANDA208784
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: LANSOPRAZOLE
- Indication: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 28 September 2017
- Application: ANDA207156
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 29 September 2017
- Application: ANDA207157
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 17 October 2018
- Application: ANDA203964
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 27 November 2018
- Application: ANDA200816
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: LANSOPRAZOLE
- Indication: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 18 May 2020
- Application: ANDA203083
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 1 February 2021
- Application: ANDA210465
- Marketing authorisation holder: DR REDDYS
- Local brand name: LANSOPRAZOLE
- Indication: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 28 March 2023
- Application: ANDA207167
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: LANSOPRAZOLE
- Indication: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 4 November 2024
- Application: ANDA208671
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: LANSOPRAZOLE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
Other Gastroenterology approved in United States
Frequently asked questions
Is Proton pump inhibitor approved in United States?
Yes. FDA authorised it on 14 November 2003; FDA authorised it on 27 May 2004; FDA authorised it on 18 May 2009.
Who is the marketing authorisation holder for Proton pump inhibitor in United States?
TAKEDA PHARMS NA holds the US marketing authorisation.