FDA — authorised 27 May 2010
- Application: NDA021253
- Marketing authorisation holder: CHEPLAPHARM
- Indication: Labeling
- Status: approved
🇺🇸 Zyprexa in United States
FDA authorised Zyprexa on 27 May 2010
Marketing authorisations
FDA — authorised 24 October 2011
- Application: ANDA076133
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: OLANZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 October 2011
- Application: ANDA201588
- Marketing authorisation holder: SANDOZ INC
- Local brand name: OLANZAPINE
- Indication: POWDER — INTRAMUSCULAR
- Status: approved
FDA — authorised 24 October 2011
- Application: ANDA091265
- Marketing authorisation holder: APOTEX INC
- Local brand name: OLANZAPINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 24 October 2011
- Application: ANDA076534
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: OLANZAPINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 25 October 2011
- Application: ANDA091415
- Marketing authorisation holder: TORRENT
- Local brand name: OLANZAPINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 28 February 2012
- Application: ANDA090881
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: OLANZAPINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 20 March 2012
- Application: ANDA201741
- Marketing authorisation holder: AM REGENT
- Local brand name: OLANZAPINE
- Indication: POWDER — INTRAMUSCULAR
- Status: approved
FDA — authorised 23 April 2012
- Application: ANDA090798
- Marketing authorisation holder: APOTEX INC
- Local brand name: OLANZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 April 2012
- Application: ANDA091434
- Marketing authorisation holder: TORRENT PHARMS LTD
- Local brand name: OLANZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 April 2012
- Application: ANDA076866
- Marketing authorisation holder: NATCO PHARMA
- Local brand name: OLANZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 April 2012
- Application: ANDA076255
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: OLANZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 April 2012
- Application: ANDA202287
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: OLANZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 May 2014
- Application: ANDA202285
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: OLANZAPINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 15 May 2014
- Application: ANDA203708
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: OLANZAPINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 15 August 2014
- Application: ANDA202862
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: OLANZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 2015
- Application: ANDA202937
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: OLANZAPINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 20 October 2015
- Application: ANDA202295
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
FDA — authorised 27 January 2016
- Application: ANDA204319
- Marketing authorisation holder: QILU
- Local brand name: OLANZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 March 2016
- Application: ANDA203333
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: OLANZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 August 2016
- Application: ANDA206711
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: OLANZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 2017
- Application: ANDA204320
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: OLANZAPINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 16 June 2017
- Application: ANDA204866
- Marketing authorisation holder: HIKMA
- Local brand name: OLANZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 July 2018
- Application: ANDA090459
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: OLANZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 2018
- Application: ANDA209399
- Marketing authorisation holder: JIANGSU HANSOH PHARM
- Local brand name: OLANZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 November 2018
- Application: ANDA206238
- Marketing authorisation holder: SUNSHINE
- Local brand name: OLANZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 September 2020
- Application: ANDA200221
- Marketing authorisation holder: JUBILANT GENERICS
- Indication: Labeling
- Status: approved
FDA — authorised 26 August 2021
- Application: ANDA078109
- Marketing authorisation holder: STRIDES PHARMA INTL
- Indication: Labeling
- Status: approved
FDA — authorised 24 February 2023
- Application: ANDA210022
- Marketing authorisation holder: CADILA PHARMS LTD
- Local brand name: OLANZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 March 2023
- Application: ANDA202889
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: OLANZAPINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 22 March 2023
- Application: ANDA217466
- Marketing authorisation holder: ASPIRO
- Local brand name: OLANZAPINE
- Indication: POWDER — INTRAMUSCULAR
- Status: approved
FDA — authorised 11 June 2025
- Application: ANDA211072
- Marketing authorisation holder: UBI
- Local brand name: OLANZAPINE
- Indication: POWDER — INTRAMUSCULAR
- Status: approved
FDA — authorised 5 March 2026
- Application: ANDA220323
- Marketing authorisation holder: ANTHEA PHARMA
- Local brand name: OLANZAPINE
- Indication: POWDER — INTRAMUSCULAR
- Status: approved
FDA
- Application: ANDA077993
- Marketing authorisation holder: ROXANE
- Local brand name: OLANZAPINE
- Indication: TABLET — ORAL
- Status: approved
Zyprexa in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Zyprexa approved in United States?
Yes. FDA authorised it on 27 May 2010; FDA authorised it on 24 October 2011; FDA authorised it on 24 October 2011.
Who is the marketing authorisation holder for Zyprexa in United States?
CHEPLAPHARM holds the US marketing authorisation.