FDA — authorised 19 July 2006
- Application: ANDA077938
- Marketing authorisation holder: PURACAP PHARM
- Local brand name: MELOXICAM
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 N1539 in United States
FDA authorised N1539 on 19 July 2006
Marketing authorisations
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: ANDA077935
- Marketing authorisation holder: TP ANDA HOLDINGS
- 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: ANDA077936
- Marketing authorisation holder: CHARTWELL RX
- 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 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: 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 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 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 9 March 2021
- Application: ANDA211398
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: MELOXICAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 June 2025
- Application: NDA218395
- Marketing authorisation holder: AZURITY
- Local brand name: XIFYRM
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- Status: approved
N1539 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 N1539 approved in United States?
Yes. FDA authorised it on 19 July 2006; FDA authorised it on 19 July 2006; FDA authorised it on 19 July 2006.
Who is the marketing authorisation holder for N1539 in United States?
PURACAP PHARM holds the US marketing authorisation.