FDA — authorised 31 January 1991
- Marketing authorisation holder: WYETH PHARMS INC
- Status: approved
🇺🇸 Lodine in United States
FDA authorised Lodine on 31 January 1991
Marketing authorisations
FDA — authorised 31 January 1991
- Application: NDA018922
- Marketing authorisation holder: WYETH PHARMS INC
- Local brand name: LODINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 February 1997
- Application: ANDA074846
- Marketing authorisation holder: SHREE HARI INTL
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 February 1997
- Application: ANDA074883
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 February 1997
- Application: ANDA074819
- Marketing authorisation holder: OXFORD PHARMS
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 April 1997
- Application: ANDA074903
- Marketing authorisation holder: PANGEA
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 1997
- Application: ANDA074892
- Marketing authorisation holder: WATSON LABS
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 May 1997
- Application: ANDA074932
- Marketing authorisation holder: NATCO PHARMA
- Local brand name: ETODOLAC
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 June 1997
- Application: ANDA074841
- Marketing authorisation holder: CHARTWELL MOLECULES
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 July 1997
- Application: ANDA074899
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ETODOLAC
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 July 1997
- Application: ANDA074839
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 July 1997
- Application: ANDA074842
- Marketing authorisation holder: CHARTWELL MOLECULES
- Local brand name: ETODOLAC
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 August 1997
- Application: ANDA074840
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ETODOLAC
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 September 1997
- Application: ANDA074942
- Marketing authorisation holder: SANDOZ
- Local brand name: ETODOLAC
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 October 1997
- Application: ANDA074927
- Marketing authorisation holder: BIOPHARM
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 November 1997
- Application: ANDA075009
- Marketing authorisation holder: TEVA
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 1997
- Application: ANDA074844
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ETODOLAC
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 January 1998
- Application: ANDA074929
- Marketing authorisation holder: BIOPHARM
- Local brand name: ETODOLAC
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 March 1998
- Application: ANDA075074
- Marketing authorisation holder: TARO PHARM INDS
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 1998
- Application: ANDA075069
- Marketing authorisation holder: WATSON LABS
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 April 1998
- Application: ANDA075078
- Marketing authorisation holder: TARO
- Local brand name: ETODOLAC
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 September 1998
- Application: ANDA075071
- Marketing authorisation holder: MYLAN
- Local brand name: ETODOLAC
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 September 1998
- Application: ANDA075012
- Marketing authorisation holder: MYLAN
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 November 1998
- Application: ANDA075226
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 April 1999
- Application: ANDA074847
- Marketing authorisation holder: TEVA
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 July 2000
- Application: ANDA075665
- Marketing authorisation holder: TEVA
- Local brand name: ETODOLAC
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
The FDA approved Lodine, a drug product, for marketing in the United States on November 21, 2024. The marketing authorization holder is TEVA. The approval was granted under the standard expedited pathway. Lodine's labeling will include the approved indication.
FDA — authorised 30 November 2001
- Application: ANDA075829
- Marketing authorisation holder: WATSON LABS FLORIDA
- Local brand name: ETODOLAC
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 8 May 2002
- Application: ANDA075126
- Marketing authorisation holder: ANI PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 26 July 2002
- Application: ANDA075943
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ETODOLAC
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 March 2003
- Application: ANDA076174
- Marketing authorisation holder: TARO
- Local brand name: ETODOLAC
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 4 April 2006
- Application: ANDA076004
- Marketing authorisation holder: APOTEX
- Indication: Labeling
- Status: approved
FDA — authorised 23 January 2014
- Application: ANDA091134
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ETODOLAC
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 7 June 2018
- Application: ANDA208834
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 November 2018
- Application: ANDA209888
- Marketing authorisation holder: ADAPTIS
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 November 2020
- Application: ANDA212263
- Marketing authorisation holder: UNICHEM
- Local brand name: ETODOLAC
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 December 2020
- Application: ANDA210704
- Marketing authorisation holder: PHARMACO
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 May 2024
- Application: ANDA204729
- Marketing authorisation holder: IPCA LABS LTD
- Local brand name: ETODOLAC
- Indication: TABLET — ORAL
- Status: approved
Lodine 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 Lodine approved in United States?
Yes. FDA authorised it on 31 January 1991; FDA authorised it on 31 January 1991; FDA authorised it on 28 February 1997.
Who is the marketing authorisation holder for Lodine in United States?
WYETH PHARMS INC holds the US marketing authorisation.