FDA — authorised 30 December 1991
- Application: NDA019091
- Marketing authorisation holder: PROMIUS PHARMA
- Local brand name: ISMO
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Monoket in United States
FDA authorised Monoket on 30 December 1991
Marketing authorisations
FDA — authorised 30 December 1991
- Status: approved
FDA — authorised 30 June 1993
- Application: NDA020215
- Marketing authorisation holder: OMNIVIUM PHARMS
- Local brand name: MONOKET
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 September 1998
- Application: ANDA075041
- Marketing authorisation holder: ALKERMES GAINESVILLE
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 October 1998
- Application: ANDA075155
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 October 1998
- Application: ANDA075037
- Marketing authorisation holder: GENUS
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 1998
- Application: ANDA075147
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 December 1998
- Application: ANDA075306
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 7 October 1999
- Application: ANDA075166
- Marketing authorisation holder: SKYEPHARMA AG
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 March 2000
- Application: ANDA075395
- Marketing authorisation holder: ZYDUS HLTHCARE
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 April 2000
- Application: ANDA075522
- Marketing authorisation holder: DEXCEL LTD
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 June 2000
- Application: ANDA075448
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 5 October 2000
- Application: ANDA075361
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 January 2005
- Application: ANDA076813
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 11 August 2010
- Application: ANDA090598
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 June 2011
- Application: ANDA200495
- Marketing authorisation holder: TORRENT PHARMS
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 June 2011
- Application: ANDA200270
- Marketing authorisation holder: TORRENT PHARMS
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 October 2017
- Application: ANDA209684
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 August 2018
- Application: ANDA210822
- Marketing authorisation holder: DEXCEL LTD
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
The FDA approved Monoket, a medication, on July 14, 2025. The approval was granted to DEXCEL LTD under the standard expedited pathway. The drug's labeling was approved for its indicated use.
FDA — authorised 5 November 2018
- Application: ANDA210918
- Marketing authorisation holder: RICONPHARMA LLC
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 April 2022
- Application: ANDA214115
- Marketing authorisation holder: SHANDONG
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 7 November 2022
- Application: ANDA216557
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 February 2024
- Application: ANDA218255
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ISOSORBIDE MONONITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Monoket 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 Monoket approved in United States?
Yes. FDA authorised it on 30 December 1991; FDA authorised it on 30 December 1991; FDA authorised it on 30 June 1993.
Who is the marketing authorisation holder for Monoket in United States?
PROMIUS PHARMA holds the US marketing authorisation.