FDA — authorised 19 October 1993
- Application: ANDA074174
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: ALPRAZOLAM
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Niravam in United States
FDA authorised Niravam on 19 October 1993
Marketing authorisations
FDA — authorised 31 October 1993
- Application: ANDA074312
- Marketing authorisation holder: HIKMA
- Local brand name: ALPRAZOLAM
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 31 October 1993
- Application: ANDA074342
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: ALPRAZOLAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 1993
- Application: ANDA074314
- Marketing authorisation holder: ROXANE
- Local brand name: ALPRAZOLAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 27 January 1994
- Application: ANDA074215
- Marketing authorisation holder: MYLAN
- Local brand name: ALPRAZOLAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 July 1994
- Application: ANDA074294
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: ALPRAZOLAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 March 1998
- Application: ANDA074909
- Marketing authorisation holder: SANDOZ
- Local brand name: ALPRAZOLAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 January 2006
- Application: ANDA077391
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ALPRAZOLAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 June 2006
- Application: ANDA077777
- Marketing authorisation holder: SANDOZ INC
- Local brand name: ALPRAZOLAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 31 July 2006
- Application: ANDA077725
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ALPRAZOLAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 January 2007
- Application: ANDA077741
- Marketing authorisation holder: APOTEX INC
- Local brand name: ALPRAZOLAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2007
- Application: ANDA077996
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: ALPRAZOLAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 February 2007
- Application: ANDA078056
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: ALPRAZOLAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 February 2007
- Application: ANDA077979
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ALPRAZOLAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 May 2007
- Application: ANDA077968
- Marketing authorisation holder: IMPAX LABS
- Local brand name: ALPRAZOLAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 March 2010
- Application: ANDA078561
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: ALPRAZOLAM
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 17 June 2010
- Application: ANDA090082
- Marketing authorisation holder: SUN PHARM
- Local brand name: ALPRAZOLAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 September 2010
- Application: ANDA090248
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: ALPRAZOLAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 June 2011
- Application: ANDA090871
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ALPRAZOLAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 April 2015
- Application: ANDA200739
- Marketing authorisation holder: NATCO
- Local brand name: ALPRAZOLAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 July 2015
- Application: ANDA203346
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ALPRAZOLAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 2018
- Application: ANDA207507
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ALPRAZOLAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA074199
- Marketing authorisation holder: ROXANE
- Local brand name: ALPRAZOLAM
- Indication: TABLET — ORAL
- Status: approved
Niravam in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Niravam approved in United States?
Yes. FDA authorised it on 19 October 1993; FDA authorised it on 31 October 1993; FDA authorised it on 31 October 1993.
Who is the marketing authorisation holder for Niravam in United States?
NOVITIUM PHARMA holds the US marketing authorisation.