FDA — authorised 13 April 2000
- Application: NDA020938
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: MOBIC
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Mobic in United States
FDA authorised Mobic on 13 April 2000
Marketing authorisations
FDA — authorised 13 April 2000
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Status: approved
FDA — authorised 1 June 2004
- Application: NDA021530
- Marketing authorisation holder: AVONDALE PHARMS
- Local brand name: MELOXICAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 July 2006
- Application: ANDA077923
- Marketing authorisation holder: NATCO PHARMA
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2006
- Application: ANDA077925
- Marketing authorisation holder: ROXANE
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2006
- Application: ANDA077935
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2006
- Application: ANDA077920
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2006
- Application: ANDA077921
- Marketing authorisation holder: ZYDUS PHARMS USA
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2006
- Application: ANDA077929
- Marketing authorisation holder: CIPLA
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2006
- Application: ANDA077930
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2006
- Application: ANDA077932
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2006
- Application: ANDA077933
- Marketing authorisation holder: YABAO PHARM
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2006
- Application: ANDA077936
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2006
- Application: ANDA077937
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2006
- Application: ANDA077938
- Marketing authorisation holder: PURACAP PHARM
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2006
- Application: ANDA077944
- Marketing authorisation holder: LUPIN PHARMS
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 July 2006
- Application: ANDA077934
- Marketing authorisation holder: MYLAN
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 July 2006
- Application: ANDA077931
- Marketing authorisation holder: RISING
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 October 2006
- Application: ANDA078008
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 November 2006
- Application: ANDA078102
- Marketing authorisation holder: TARO
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 December 2006
- Application: ANDA077918
- Marketing authorisation holder: YUNG SHIN PHARM
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 December 2006
- Application: ANDA078039
- Marketing authorisation holder: CR DOUBLE CRANE
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 December 2006
- Application: ANDA077927
- Marketing authorisation holder: UNICHEM
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 May 2009
- Application: ANDA077928
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2015
- Application: NDA207233
- Marketing authorisation holder: ICEUTICA OPERATIONS
- Local brand name: VIVLODEX
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 October 2018
- Application: NDA211210
- Marketing authorisation holder: TERSERA
- Local brand name: QMIIZ ODT
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 20 February 2020
- Application: NDA210583
- Marketing authorisation holder: BAUDAX
- Local brand name: ANJESO
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 1 June 2020
- Application: ANDA209487
- Marketing authorisation holder: LUPIN
- Local brand name: MELOXICAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 March 2021
- Application: ANDA211398
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: MELOXICAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 June 2023
- Application: ANDA217579
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 January 2025
- Application: NDA215431
- Marketing authorisation holder: AXSOME
- Local brand name: SYMBRAVO
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 April 2025
- Application: NDA217593
- Marketing authorisation holder: NANJING DELOVA
- Local brand name: QAMZOVA
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 5 June 2025
- Application: NDA218395
- Marketing authorisation holder: AZURITY
- Local brand name: XIFYRM
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Mobic in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Mobic approved in United States?
Yes. FDA authorised it on 13 April 2000; FDA authorised it on 13 April 2000; FDA authorised it on 1 June 2004.
Who is the marketing authorisation holder for Mobic in United States?
BOEHRINGER INGELHEIM holds the US marketing authorisation.