FDA — authorised 12 April 1988
- Status: approved
🇺🇸 Axid Ar in United States
FDA authorised Axid Ar on 12 April 1988
Marketing authorisations
FDA — authorised 9 May 1996
- Application: NDA020555
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: AXID AR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 July 2002
- Application: ANDA075806
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: NIZATIDINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 July 2002
- Application: ANDA076178
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: NIZATIDINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 July 2002
- Application: ANDA075461
- Marketing authorisation holder: ANI PHARMS
- Local brand name: NIZATIDINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 July 2002
- Application: ANDA075934
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: NIZATIDINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 July 2002
- Application: ANDA075616
- Marketing authorisation holder: WATSON LABS
- Local brand name: NIZATIDINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 September 2002
- Application: ANDA075668
- Marketing authorisation holder: ANI PHARMS
- Local brand name: NIZATIDINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 January 2003
- Application: ANDA076383
- Marketing authorisation holder: APOTEX INC
- Local brand name: NIZATIDINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 September 2005
- Application: ANDA077314
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: NIZATIDINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 November 2009
- Application: ANDA090576
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: NIZATIDINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 15 July 2011
- Application: ANDA090618
- Marketing authorisation holder: GLENMARK PHARMS
- Local brand name: NIZATIDINE
- Indication: CAPSULE — ORAL
- Status: approved
Axid Ar in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Axid Ar approved in United States?
Yes. FDA authorised it on 12 April 1988; FDA authorised it on 9 May 1996; FDA authorised it on 5 July 2002.
Who is the marketing authorisation holder for Axid Ar in United States?
Marketing authorisation holder not available in our data.