FDA — authorised 4 June 1965
- Application: NDA015539
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: SERAX
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 EMB-01 in United States
FDA authorised EMB-01 on 4 June 1965
Marketing authorisations
FDA — authorised 16 January 1987
- Application: ANDA070683
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: OXAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 August 1987
- Application: ANDA070945
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: OXAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 August 1987
- Application: ANDA070943
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: OXAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 August 1987
- Application: ANDA070944
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: OXAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 August 1987
- Application: ANDA071026
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: OXAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 April 1988
- Application: ANDA072253
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: OXAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 April 1988
- Application: ANDA071756
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: OXAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 June 1989
- Application: ANDA070641
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: ZAXOPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 June 1989
- Application: ANDA070640
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: ZAXOPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 March 2025
- Application: ANDA218261
- Marketing authorisation holder: LEADING
- Local brand name: OXAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070650
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: ZAXOPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA071714
- Marketing authorisation holder: MYLAN
- Local brand name: OXAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA071713
- Marketing authorisation holder: MYLAN
- Local brand name: OXAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
Other Oncology approved in United States
Frequently asked questions
Is EMB-01 approved in United States?
Yes. FDA authorised it on 4 June 1965; FDA authorised it on 16 January 1987; FDA authorised it on 3 August 1987.
Who is the marketing authorisation holder for EMB-01 in United States?
ALPHARMA US PHARMS holds the US marketing authorisation.