FDA — authorised 25 May 2001
- Application: NDA021301
- Marketing authorisation holder: KING PHARMS
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
🇺🇸 Unithroid in United States
FDA authorised Unithroid on 25 May 2001
Marketing authorisations
FDA — authorised 1 March 2002
- Application: NDA021342
- Marketing authorisation holder: CEDIPROF INC
- Local brand name: LEVO-T
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 June 2002
- Application: ANDA076187
- Marketing authorisation holder: MYLAN
- Local brand name: LEVOTHYROXINE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 October 2002
- Application: NDA021116
- Marketing authorisation holder: ALVOGEN
- Local brand name: THYRO-TABS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 June 2003
- Application: NDA021137
- Marketing authorisation holder: GENUS LIFESCIENCES
- Local brand name: LEVOLET
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 June 2004
- Application: ANDA076764
- Marketing authorisation holder: MYLAN
- Local brand name: LEVOTHYROXINE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 June 2005
- Application: ANDA076752
- Marketing authorisation holder: MERCK KGAA
- Local brand name: LEVOTHYROXINE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 2009
- Application: NDA021292
- Marketing authorisation holder: EMD SERONO INC
- Indication: Labeling
- Status: approved
FDA — authorised 24 June 2011
- Application: NDA202231
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: LEVOTHYROXINE SODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 21 December 2018
- Application: ANDA208749
- Marketing authorisation holder: MAIA PHARMS INC
- Local brand name: LEVOTHYROXINE SODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 18 January 2019
- Application: ANDA209713
- Marketing authorisation holder: LUPIN
- Local brand name: LEVOTHYROXINE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 October 2020
- Application: ANDA212399
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: LEVOTHYROXINE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 November 2020
- Application: NDA214047
- Marketing authorisation holder: STEVENS J
- Local brand name: THYQUIDITY
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 6 January 2021
- Application: ANDA213256
- Marketing authorisation holder: ANI PHARMS
- Local brand name: LEVOTHYROXINE SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 April 2022
- Application: NDA215809
- Marketing authorisation holder: MYLAN
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 10 May 2022
- Application: ANDA207588
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: LEVOTHYROXINE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 December 2022
- Application: ANDA211417
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: LEVOTHYROXINE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 January 2023
- Application: ANDA215259
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: LEVOTHYROXINE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 March 2023
- Application: ANDA217066
- Marketing authorisation holder: ZYDUS PHARMS
- Status: approved
FDA — authorised 16 July 2024
- Application: ANDA216414
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: LEVOTHYROXINE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 November 2024
- Application: ANDA217495
- Marketing authorisation holder: XIROMED
- Local brand name: LEVOTHYROXINE SODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
Unithroid in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Unithroid approved in United States?
Yes. FDA authorised it on 25 May 2001; FDA authorised it on 1 March 2002; FDA authorised it on 5 June 2002.
Who is the marketing authorisation holder for Unithroid in United States?
KING PHARMS holds the US marketing authorisation.